Zimmer Spine, Inc.
Minneapolis, MN, US
Zimmer Spine, Inc. appears in FDA device records in Minneapolis, MN. FDA records list 50 510(k) clearances between and , 18 PMA records and no registered establishments. As of , FDA records show 7 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Zimmer Spine, Inc. 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.
- Sulzer Spine-Tech510(k), PMA, recall
510(k) clearance history
FDA records hold 50 510(k) clearances for Zimmer Spine, Inc. between 1999 and 2016. The busiest year on record is 2013, with 9. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 2 |
| 2001 | 2 |
| 2002 | 3 |
| 2004 | 2 |
| 2005 | 1 |
| 2006 | 2 |
| 2007 | 3 |
| 2008 | 2 |
| 2009 | 2 |
| 2010 | 2 |
| 2011 | 5 |
| 2012 | 2 |
| 2013 | 9 |
| 2014 | 7 |
| 2015 | 5 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K153631 | Zimmer Virage OCT Spinal Fixation System | NKG | Substantially Equivalent | |
| K150896 | Vitality Spinal Fixation System | NKB | Substantially Equivalent | |
| K151031 | Virage OCT Spinal Fixation System | NKG | Substantially Equivalent | |
| K142752 | Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System | NKB | Substantially Equivalent | |
| K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System | KWQ | Substantially Equivalent | |
| K143297 | Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) | MAX | Substantially Equivalent | |
| K142053 | UNIVERSAL CLAMP SPINAL FIXATION SYSTEM | OWI | Substantially Equivalent | |
| K141500 | OPTIO-C ANTERIOR CERVICAL SYSTEM | KWQ | Substantially Equivalent | |
| K133556 | VIRAGE OCT SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | |
| K140611 | TRINICA ANTERIOR LUMBAR PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K133184 | ARDIS INTERBODY SYSTEM | MAX | Substantially Equivalent | |
| K133164 | DYNESYS TOP-LOADING SPINAL SYSTEM | NQP | Substantially Equivalent | |
| K132894 | OPTIO-C ANTERIOR CERVICAL SYSTEM | OVE | Substantially Equivalent | |
| K132790 | INFIX ANTERIOR LUMBAR SYSTEM | MAX | Substantially Equivalent | |
| K133291 | ST360 DEGREES SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | |
| K133086 | TITLE 2 POLYAXIAL SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K132884 | PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | |
| K131980 | SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM | NKB | Substantially Equivalent | |
| K131242 | ARDIS INTERBODY SYSTEM | MAX | Substantially Equivalent | |
| K132012 | TRINICA(R) ANTERIOR CERVICAL PLATE SYSTEM, TRINICA(R) SELECT ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K123552 | INSTINCT JAVA SYSTEM | NKB | Substantially Equivalent | |
| K122592 | INSTINCT JAVA SYSTEM | MNH | Substantially Equivalent | |
| K122733 | V2F ANTERIOR FIXATION SYSTEM | KWQ | Substantially Equivalent | |
| K121671 | PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | |
| K113270 | INSTINCT JAVA SYSTEM | NKB | Substantially Equivalent | |
| K111119 | TRABECULAR METAL (TM) FUSION DEVICE | ODP | Substantially Equivalent | |
| K111796 | INVIZIA ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K111301 | INSTINCT JAVA SYSTEM | NKB | Substantially Equivalent | |
| K110348 | UNIVERSAL CLAMP SPINAL FIXATION SYSTEM | OWI | Substantially Equivalent | |
| K100845 | PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES | NKB | Substantially Equivalent | |
| K101704 | ZIMMER DTO PIN PRESS INSTRUMENT | NQP | Substantially Equivalent | |
| K092234 | DYNESYS TOP-LOADING SPINAL SYSTEM | NQP | Substantially Equivalent | |
| K091190 | UNIVERSAL CLAMP STAINLESS STEEL SYSTEM, MODELS SNA027-0-30060, SNA027-0-30063 | JDQ | Substantially Equivalent | |
| K080367 | ZIMMER MIS LIGHT | FST | Substantially Equivalent | |
| K073347 | DYNESYS TOP-LOADING SPINAL SYSTEM | NQP | Unknown | |
| K071880 | Optima ZS Transition Screw | MNI | Unknown | |
| K071879 | ZIMMER DTO IMPLANT | NQP | Unknown | |
| K072183 | ST360 SPINAL FIXATION SYSTEM, MODEL 07.0029-7500.5600 | NKB | Substantially Equivalent | |
| K061353 | TRINICA ANTERIOR LUMBAR PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K060638 | DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS | NQP | Substantially Equivalent | |
| K043565 | MODIFICATION TO DYNESYS SPINAL SYSTEM | NQP | Substantially Equivalent | |
| K042702 | SILHOUETTE SPINAL FIXATION SYSTEM | NKB | Substantially Equivalent | |
| K041925 | ST360 SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | |
| K022374 | CADENCE SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | |
| K020344 | RPX TITANIUM CEMNT RESTRICTOR | JDK | Substantially Equivalent | |
| K020196 | MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM | MNH | Substantially Equivalent | |
| K012173 | DEVICE MODIFICATION OF SILHOUETTE SPINDAL FIXATION SYSTEM | KWP | Substantially Equivalent | |
| K012305 | MODIFICATION TO: TRINICA ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K993067 | SILHOUETTE SPINAL FIXATION SYSTEM | KWP | Substantially Equivalent | |
| K992276 | MODIFICATION TO SILHOUETTE SPINAL FIXATION SYSTEM | MNI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- OWIBone Fixation Cerclage, Sublaminar
- JDQCerclage, Fixation
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- FSTLight, Surgical, Fiberoptic
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- NKGPosterior Cervical Screw System
- NQPPosterior Metal/Polymer Spinal System, Fusion
- JDKProsthesis, Hip, Cement Restrictor
- NKBThoracolumbosacral Pedicle Screw System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1190-2016 | Instinct Java System (IFU reference: 046WAN0000T) . Stabilizes one or more vertebral segments from the thoracic spine to the sacrum during the development of bone tissue. | Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct Java System (IFU reference: 046WAN0000T) and Universal Clamp System (IFU reference: SNA027-N-90001). | Class II | Terminated | |
| Z-1189-2016 | Universal Clamp System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures. | Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct Java System (IFU reference: 046WAN0000T) and Universal Clamp System (IFU reference: SNA027-N-90001). | Class II | Terminated | |
| Z-1019-2016 | Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3). | Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fixation System by providing additional guidance in the Virage OCT Surgical Technique Manual. | Class II | Terminated | |
| Z-0190-2007 | Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Part number: 07.00684.00. Non-Sterile. Zimmer Spine, Inc., 7375 Bush Lake Road, Minneapolis, MN 55439 U.S.A. The Distal Thread Reduction Guide Pin is a reusable instrument that is part of a set of instruments used to perform reduction surgeries with the ST360 Spinal Fixation System. The ST360 Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. This system includes polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varying lengths, hooks in varying designs, fixed and adjustable transverse connectors. | Zimmer Spine, Inc. is conducting a RECALL of all manufacturing lots of ST360 Distal Thread Reduction Guide Pins due to an issue with the thread timing. | Terminated | ||
| Z-0040-05 | ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays. | To date, there has been one complaint reported. During a Trinica surgical case, the surgeon was provided a standard disposable, Trinica Drill Bit (part number 07.00166.001) for use with the Trinica All Through One Drill Guide Instrumentation, instead of the ALL Through One Drill Bit. This enabled the physician to drill a few millimeters further than expected. | Terminated | ||
| Z-1014-04 | Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Only the Trinica Bone Tap Instruments are being recalled from the sets. | The recalled bone taps could break inside the vertebral body during the tapping process. | Terminated | ||
| Z-0559-03 | Spine-Tech Ancillary Discectomy Instrument (Box Curette), Catalog Number 07.00254.001, in Spine-Tech Ancillary Discectomy Instrument Set, Catalog Number 07.00316.001. | With 14 units distributed, there have been 10 complaints of the product having a twisted or broken tip. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain