Theken Companies LLC
Akron, OH, US
THEKEN COMPANIES, LLC appears in FDA device records in Akron, OH. FDA records list 28 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Theken Companies 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.
- Theken Spine, LLC510(k), recall
510(k) clearance history
FDA records hold 28 510(k) clearances for Theken Companies LLC between 2007 and 2022. The busiest year on record is 2007, with 6. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 6 |
| 2008 | 4 |
| 2009 | 4 |
| 2010 | 3 |
| 2011 | 2 |
| 2012 | 4 |
| 2016 | 1 |
| 2017 | 1 |
| 2019 | 2 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K220336 | Mg-PSZ Ceramic Femoral Head | LPH | Substantially Equivalent | |
| K191297 | iNSitu Bipolar Hip System | KWY | Substantially Equivalent | |
| K192071 | iNSitu Total Hip System | LPH | Substantially Equivalent | |
| K172501 | iNSitu Total Hip System | LPH | Substantially Equivalent | |
| K161184 | iNSitu Total Hip System | LPH | Substantially Equivalent | |
| K121482 | INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY | HRX | Substantially Equivalent | |
| K121211 | VU APOD INTERVERTEBRAL BODY FUSION DEVICE | OVD | Substantially Equivalent | |
| K120829 | STAINLESS STEEL SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K120047 | CORAL SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K111675 | VU C*POD INTERVERTEBRAL BODY FUSION DEVICE | ODP | Substantially Equivalent | |
| K103228 | PARAMOUNT R IBF DEVICE | MAX | Substantially Equivalent | |
| K102323 | CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICE | OVE | Substantially Equivalent | |
| K101310 | VU APOD INTERVERTEBRAL BODY FUSION DEVICE | OVD | Substantially Equivalent | |
| K100970 | STAINLESS STEEL SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K091266 | THEKEN CORAL SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K083863 | THEKEN ATOLL OCT SPINAL SYSTEM | MNI | Substantially Equivalent | |
| K083073 | THEKEN ATOLL CERVICO-THORACIC SYSTEM | MNI | Substantially Equivalent | |
| K082712 | THEKEN SPINE VU EPOD AND VU LPOD SYSTEM | MAX | Substantially Equivalent | |
| K080822 | VU APOD INTERVERTABRAL BODY FUSION DEVICE | OVD | Substantially Equivalent | |
| K081414 | MODIFICATION TO CORAL SPINAL SYSTEM | NKB | Substantially Equivalent | |
| K080790 | MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM | KWP | Substantially Equivalent | |
| K080690 | MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K072407 | BODYFORM THORACIC FIXATION SYSTEM | KWQ | Substantially Equivalent | |
| K070962 | CORAL PEDICLE SCREW SYSTEM | NKB | Substantially Equivalent | |
| K071031 | VU E*POD VERTEBRAL BODY REPLACEMENT | MQP | Substantially Equivalent | |
| K070786 | X-POD ADJUSTABLE VERTEBRAL BODY REPLACEMENT | MQP | Substantially Equivalent | |
| K070638 | THEKEN ATOLL CERVICO-THORACIC SYSTEM | KWP | Substantially Equivalent | |
| K070381 | THEKEN VU MESH VBR SYSTEM | MQP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3002498892 | 3002498892 | THEKEN COMPANIES, LLC | 1800 Triplett Blvd, Akron, OH 44306 US | 2026 | and 15 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HRXArthroscope
- HTWBit, Drill
- HTQBroach
- HWBExtractor
- HTDForceps
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
- KIKHook, Bone
- HWAImpactor
- HTZInstrument, Cutting, Orthopedic
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- LXHOrthopedic Manual Surgical Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- GFIOsteotome, Manual
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- HTRRasp
- HTOReamer
- GADRetractor
- HXXScrewdriver
- MQPSpinal Vertebral Body Replacement Device
- HWTTemplate
- NKBThoracolumbosacral Pedicle Screw System
- FSMTray, Surgical, Instrument
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0227-2026 | iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar Head Assembly, Size 40mm 10-22-0042 Bipolar Head Assembly, Size 42mm 10-22-0044 Bipolar Head Assembly, Size 44mm 10-22-0046 Bipolar Head Assembly, Size 46mm 10-22-0048 Bipolar Head Assembly, Size 48mm 10-22-0050 Bipolar Head Assembly, Size 50mm 10-22-0052 Bipolar Head Assembly, Size 52mm 10-22-0054 Bipolar Head Assembly, Size 54mm 10-22-0056 Bipolar Head Assembly, Size 56mm 10-22-0058 Bipolar Head Assembly, Size 58mm 10-22-0060 Bipolar Head Assembly, Size 60mm | Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier. | Class II | Open, Classified | |
| Z-0169-2011 | Bone Void Filler, sterile orthopedic product, 510 (k) #K053228. The product is delivered in a syringe which is packaged in an aluminum-backed polyethylene pouch and is distributed one (1) pouch per box. The product affected by this recall was distributed by the recalling firm under six (6) different names. They are: Form-Putty; SBvFShape; Valeo BP; X-Putty; TheriGraft Putty; and SynFlow. The product is indicated for use in filling the gaps or voids of osseous defects surgically created or resulting from trauma and are intended for treatment of osseous defects not intrinsic to the stability of the bone structure. The products are intended for use in defects of the skeletal system (i. e. the extremities, spine and pelvis). | The firm's quality control testing determined that a separation was occurring between the flowable carrier and the B-TriCalcium Phosphate within some of the product syringes. | Terminated | ||
| Z-0087-2011 | Manta Ray: Anterior Cervical Plate (ACP) System, 510 (k) #K080690. The labeling for the plate component reads in part: 'REF: 22-'**** MAT'L: Titanium per ASTM F-136, Lot: W****, Description: Plate - 40 mm, Qty: 1.' The labeling for the screw component reads in part: 'REF: 22-**** MAT'L: Titanium per ASTM F-136 LOT W**** Description: Screw-Fixed Tapping 4x10mm QTY: 1. Manta Ray Anterior Cervical Plate (ACP) System is intended for temporary stabilization of the cervical spine C2-C7 due to the following indications: DDD (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); Spondylolisthesis; Trauma (i.e. fracture/dislocation); Tumor; Spinal stenosis; Deformity (i. e. scoliosis, kyphosis and/or lordosis); Pseudoarthrosis; and Failed previous fusion. | The Manta Ray Cervical System was subject to corrective action by the firm after two (2) customer complaints were received alleging that screws were 'backing out' of the device during surgical procedures. | Terminated | ||
| Z-0272-2009 | Bone Marrow Aspiration Kit, consists of 3 main components packaged in a box. 1. Marrow Loc (Bone Marrow Specimen Acquisition System), 2. "J" Style Bone Marrow Biopsy Needle (11g (3.0mm)x10cm (4.0)) 3. BD 20ml Syringe. | The kits were manufactured in 2005 with syringes that expire on 10/2009 and labeled with an overall expiration on 10/2010. | Terminated | ||
| Z-1965-2009 | iLink Bone Void Filler. Packaged in a double Tyvek pouch, then placed in a box. Model Number: 50-05-0010, Exp. 2010-04. | Failure to label the product properly. Additionally, 15 pieces were reworked and the expiration date was misprinted as 2011-04 instead of the actual date of 2010-04. | Terminated | ||
| Z-2375-2008 | FormPutty Bone Void Filler 10cc The product is sealed in a foil pouch and then placed in a box following sterilization. Part # 50-07-0100 Is a flowable resorbable porous bone void filler composed of beta tricalcium phosphate and other calcium phosphates. | The patient label inside the package has an expiration date of 2008-06 when the actual expiration date is 2010-06. | Terminated | ||
| Z-0183-06 | Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System). | The torque value of the device may increase over time. The increase could exceed the tolerance specification. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain