Highridge Medical, LLC

Westminster, CO, US

Highridge Medical, LLC appears in FDA device records in Westminster, CO. FDA records list 40 510(k) clearances between 2007-04-04 and 2025-12-17, 81 PMA records and one registered establishment. As of 2026-09-10, FDA records show 23 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 40
PMA records: 81
Recall records: 23
Registered establishments: 1

FDA records under these names

3 names

FDA records resolved to Highridge Medical, LLC carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

Biomet Spine, LLC510(k), enforcement report, recall
Lanx, Inc.recall
Zimmer Biomet Spine, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 40 510(k) clearances for Highridge Medical, LLC between 2007 and 2025. The busiest year on record is 2008, with 5. The most recent is 2025, with 2.

Clearances by year, as a table

510(k) clearance decisions for Highridge Medical, LLC, by decision year
Year	Clearances
2007	3
2008	5
2009	2
2010	1
2011	2
2012	1
2014	2
2015	5
2016	2
2017	3
2018	2
2019	5
2020	1
2021	4
2025	2

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K253093	Vital™ Spinal Fixation System	NKB	Substantially Equivalent	2025-12-17
K250332	Virage® OCT Spinal Fixation System	NKG	Substantially Equivalent	2025-04-04
K212023	Virage Navigation System	OLO	Substantially Equivalent	2021-08-27
K203218	CaP Spheres Pellet Pack	MQV	Substantially Equivalent	2021-05-04
K210275	Polaris Spinal System	NKB	Substantially Equivalent	2021-04-02
K203507	Vitality® Spinal Fixation System	NKB	Substantially Equivalent	2021-01-28
K202309	Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System	KWQ	Substantially Equivalent	2020-10-08
K191722	Vital Navigation System	OLO	Substantially Equivalent	2019-12-02
K192133	Zimmer Biomet Universal Navigation System	OLO	Substantially Equivalent	2019-10-29
K190556	Zimmer Biomet Universal Navigation System	OLO	Substantially Equivalent	2019-10-24
K183550	Vitality® Spinal Fixation System	NKB	Substantially Equivalent	2019-04-08
K181096	Avenue P Cage System	OVD	Substantially Equivalent	2019-01-15
K180227	Polaris Spinal Growth System	PGM	Substantially Equivalent	2018-03-15
K171495	Zyston Strut Open Titanium Spacer System	MAX	Substantially Equivalent	2018-02-12
K172275	Vitality® Spinal Fixation System, Vitality®+ Power Instrument System	NKB	Substantially Equivalent	2017-09-27
K171907	Vitality® Spinal Fixation System	NKB	Substantially Equivalent	2017-07-14
K163543	Biomet Fusion System	OVD	Substantially Equivalent	2017-02-28
K152622	Alta ACDF System	OVE	Substantially Equivalent	2016-07-08
K153695	Biomet Spine Fusion System	MAX	Substantially Equivalent	2016-01-21
K151974	Polaris Spinal System	NKB	Substantially Equivalent	2015-11-13
K151064	Solitaire-C Cervical Spacer System, C-Thru Anterior Spinal System, Breckenridge Small Intervertebral Body Fusion System	OVE	Substantially Equivalent	2015-08-12
K151483	Biomet Spine Fusion System	MAX	Substantially Equivalent	2015-07-31
K151224	Lineum OCT Spine System	NKG	Substantially Equivalent	2015-06-30
K142634	Biomet Spine Fusion System	MAX	Substantially Equivalent	2015-03-12
K141791	BIOMET FUSION SYSTEM	OVD	Substantially Equivalent	2014-10-09
K141804	POLARIS SPINAL SYSTEM - HA COATED	NKB	Substantially Equivalent	2014-09-25
K121130	POLARIS SPINAL SYSTEM-BALLISTA SPINAL RODS	NKB	Substantially Equivalent	2012-06-15
K112014	ZYSTON STRAIGHT SPACER SYSTEM	MAX	Substantially Equivalent	2011-10-17
K103393	POLARIS SPINAL SYSTEM	KWQ	Substantially Equivalent	2011-02-02
K093629	SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM	OVD	Substantially Equivalent	2010-03-09
K091067	5.5 POLARIS SPINAL SYSTEM	NKB	Substantially Equivalent	2009-07-14
K082793	INTERGRO DBM	MQV	Substantially Equivalent	2009-04-02
K081952	SYNERGY SPINAL SYSTEM (6.35 POLARIS)	NKB	Substantially Equivalent	2008-10-07
K081636	PEEK-OPTIMA ALIF SPACER	MAX	Substantially Equivalent	2008-08-07
K081501	SOLITAIRE ANTERIOR SPINAL SYSTEM	OVD	Substantially Equivalent	2008-07-02
K081395	SOLITAIRE PEEK-OPTIMA ANTERIOR SPINAL SYSTEM	OVD	Substantially Equivalent	2008-06-25
K080646	C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM	KWQ	Substantially Equivalent	2008-05-02
K071377	POLARIS BE RODS	KWP	Substantially Equivalent	2007-08-06
K063393	SMALL STATURE SPACERS	MQP	Substantially Equivalent	2007-06-25
K063139	SPINAL STABILIZING SPHERE SYSTEM	NVR	Unknown	2007-04-04

Registered establishments

FDA registered establishments for Highridge Medical, LLC, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3012447612	3012447612	Highridge Medical, LLC	10225 Westmoor Dr, Westminster, CO 80021 US	2026	BWN DZK FDG FEM FSM FST FTY FZO FZT FZX and 102 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0639-2024	Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System	Spinal fixation system 7.5mmx 50mm screws are packaged with the correct labeling, but the screws themselves were laser marked with an incorrect size description of 7.5 x 40; use of incorrect screws could lead to screw perforation and indention of vascular or other structures.	Class II	2023-10-16	Open, Classified
Z-0868-2019	Vitality Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications	The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications	Class II	2018-07-30	Terminated
Z-0867-2019	Vitality Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications.	The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications	Class II	2018-07-30	Terminated
Z-0866-2019	Vitality Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue. These devices are indicated as an adjunct to fusion for various indications	The Vitality Shear-off Set Screw is not threading properly with the mating tulip head of the Vitality screws, hooks and connectors due to a manufacturing issue.These devices are indicated as an adjunct to fusion for various indications	Class II	2018-07-30	Terminated
Z-2318-2017	Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017	Zimmer Biomet is conducting a medical device recall for Vitality T27 Final Drivers and Vitality Torque Limiting Handle 90 in-lbs because when applying torque to tighten the closure top the driver has the potential to create a torsional spring which can cause damage and the potential for the values of torque to go out of specification.	Class II	2017-05-10	Terminated
Z-1691-2017	Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; atlantoaxial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only	Zimmer Biomet is recalling the Altius M-INI OCT Posterior Spinal Fixation System because the driver is unable to mate with the screw head tulip.	Class II	2017-03-16	Terminated
Z-2398-2016	Zyston Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.	Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston Transform Instrument Case and Zyston Transform Implant Kit because the locking mechanism on the implant is not functioning as intended.	Class II	2016-06-30	Terminated
Z-2397-2016	Zyston Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.	Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston Transform Instrument Case and Zyston Transform Implant Kit because the locking mechanism on the implant is not functioning as intended.	Class II	2016-06-30	Terminated
Z-1253-2016	10mm X 12o Solitaire Ti Medium Spacer Solitaire Anterior Spinal System, Model Number 1400-1230. Product Usage: The SOLITAIRETM SPINAL SYSTEM is designed for use with autograft and is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the SOLITAIRETM ANTERIOR SPINAL SYSTEM is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The SolitaireTM System is also indicated for treating fractures of the thoracic and lumbar spine. The SolitaireTM System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.	Zimmer Biomet Spine initiated a recall of certain Solitaire Ti Spacers because they may have a mislabeled lordotic angle of 12degrees when the angle is actually 6 degrees.	Class II	2016-02-12	Terminated
Z-0203-2016	MaxAn 4.0mm and 4.5mm fixed screws, used in the MaxAn Anterior Cervical Plate System. The MaxAn Anterior Cervical Plate System is a decompression-based technique for cervical spine stabilization.	The packaging of 4.5 mm diameter MaxAn screws identifies/labels the screws as 4.0 mm diameter screws.	Class II	2015-09-29	Terminated
Z-2744-2015	Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.	Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440.	Class II	2015-08-05	Terminated
Z-2759-2015	Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch. The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic spine using bone screws, locking plugs, and various types of rods, hooks, and lateral connectors. One of the instruments used with this system is the Lineum Occipital Screw Starter with the inner shaft subassembly. The system comes with a fixed shaft Lineum Occipital Screw Driver, and a 90 driver in order to retain and drive the screw into the occipital bone.	Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities.	Class II	2015-07-22	Terminated
Z-2152-2015	Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and Bone Healing Technologies. Spinal fixation component.	Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification.	Class II	2015-03-12	Terminated
Z-1466-2015	Torque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.	Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.	Class II	2015-03-12	Terminated
Z-1465-2015	Lineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of the cervical and upper thoracic spine using bones screws, locking plugs, and various types of rods, hooks, and lateral connectors.	Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.	Class II	2015-03-12	Terminated
Z-0400-2014	LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver"). Model Number 8630-0107. The Timberline MPF device is an intervertebral body fusion device consisting of a PEEK intervertebral spacer, titanium plate, and screws. The PEEK spacer has a generally rounded shape with various heights and footprints and has a hollowed out central area to accommodate autogenous bone graft. The upper and lower surfaces have a series of transverse grooves formed to improve stability and fixation once the device is inserted. The titanium plate has holes for receiving bone screws and a central hole for receiving a cover plate to prevent screw back-out. The Timberline MPF system is available in a variety of sizes and configurations to approximate anatomical variation in different vertebral levels and/or patient anatomy. The Timberline MPF system is provided nonsterile. The Driver is used with the Timberline MPF system to drive titanium screws through the plate and into the vertebrae thus locking plate to the vertebrae.	Lanx, Inc. is recalling various lots of Timberline MPF Straight Split Tip Driver - Short ("Driver") because the width of the most distal end from the Driver handle (the tip of the hex portion of the Driver) is oversized.	Class II	2013-11-04	Terminated
Z-0983-2015	Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable Sleeves are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae. The Timberline Retractable Drill and the Timberline Retractable Awl fit within this Sleeve. Spinal Surgical Device.	The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve.	Class II	2013-08-22	Terminated
Z-0978-2015	Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.	The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve shaft.	Class II	2013-08-22	Terminated
Z-0982-2015	Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.	The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly.	Class II	2013-08-22	Terminated
Z-1146-2015	Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium alloy, commercially pure titanium or cobalt chrome rod into a pedicle screw tulip in order to create a spinal fixation construct. The Set Screw is provided to the user non-sterile and is used across three Biomet Spine product lines; Silverton Spinal Fixation System (Silverton), Silverton-D Spinal Fixation System (Silverton-D) and Telluride Minimally Invasive Spinal Fixation System (Telluride). The primary packaging for the Set Screws is an aluminum sterilization case that holds both implants and instruments used collectively as part of a system. Additionally, Set Screws can be packaged in a heat sealed polypropylene bag for single device distribution.	Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification	Class II	2012-11-30	Terminated
Z-1069-2015	Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray along with other instruments for use in a Timberline procedure Timberline Anchored Lateral Retractable Drills are used with the Timberline Lateral System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.	Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due to oversize of the set screw hex feature.	Class II	2012-02-22	Terminated
Z-1089-2015	Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. The case consists of three trays of instruments, and the middle tray contains a quantity of two Inserters. The Inserter is for use as part of a Telluride System pedicle screw procedure.	The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. There is a potential for the Rod to disengage from the Inserter during insertion, and could lead to harm to the patient.	Class II	2011-12-19	Terminated
Z-0220-2015	LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization case. Product Usage: The Durango implant is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2S1.	Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw component potentially becoming dislodged from the plate assembly.	Class II	2011-03-09	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain