Medical device manufacturer
Tornier, Inc.
Tornier, Inc. holds 96 FDA 510(k) clearances across 23 product codes. Median elapsed review time is 101 days. openFDA lists 20 recall records naming the company. FDA publishes it under 8 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 96
- Product codes
- 23
- Median review
- 101 days
- Recall records
- 20
How does FDA spell Tornier, Inc.?
FDA publishes this company under 8 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| TORNIER Inc. | device/registrationlisting | normalised |
| TORNIER, INC. | device/registrationlisting | normalised |
| TORNIER, SAS | device/registrationlisting | normalised |
| Tornier | device/510k | normalised |
| Tornier, Inc | device/recall | normalised |
| Tornier, Inc | device/enforcement | normalised |
| Tornier, Inc. | device/recall | normalised |
| Tornier, Inc. | device/510k | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Tornier, Inc. file in?
23 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 24 | 45 days | |
| PHX | Shoulder Prosthesis, Reverse Configuration | 18 | 97 days | |
| JDB | Prosthesis, Elbow, Semi-Constrained, Cemented | 9 | 108 days | |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 7 | 90 days | |
| HRS | Plate, Fixation, Bone | 4 | 112 days | |
| FTL | Mesh, Surgical, Polymeric | 3 | 228 days | |
| HSB | Rod, Fixation, Intramedullary And Accessories | 3 | 130 days | |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 3 | 30 days | |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 3 | 233 days | |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 2 | 64 days | |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 2 | 180 days | |
| HWC | Screw, Fixation, Bone | 2 | 125 days | |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 | 24 days | |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 | 28 days | |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 2 | 99 days | |
| NWJ | Suture, Recombinant Technology | 2 | 33 days | |
| PKC | Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained | 2 | 79 days | |
| JDC | Prosthesis, Elbow, Constrained, Cemented | 1 | 273 days | |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | 1 | 227 days | |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 1 | 276 days | |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 1 | 150 days | |
| LZN | Cement Obturator | 1 | 78 days | |
| PAO | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented | 1 | 116 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Tornier, Inc. had a recall?
openFDA lists 20 recall records naming this company across its whole history, of which 2 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-1769-2026Class IIOpen, ClassifiedKWS
Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.
Z-1237-2026Class IIOpen, ClassifiedKWS
A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.
Z-1651-2025Class IIOpen, ClassifiedJDB
A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Marked: 9030103, Humeral Stem Trial 150mm Large / Right, Yellow color indicator (incorrect) " Device Actually: 9030092, Humeral Stem Trial 150mm Medium / Left, Red color indicator (correct)
Z-3155-2024Class IIOpen, ClassifiedPKC
One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
Z-3309-2024Class IIOpen, ClassifiedPAO
Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.
Showing the 5 most recently initiated of 20.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Tornier, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K260721 | Tornier Perform Advanced Glenoid | KWS | 139 | |
| K252788 | Tornier Perform Reversed Monopost Glenoid (Perform Mono) | PHX | 128 | |
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max) | KWT | 150 | |
| K230352 | Tornier Humeral Nail and Tornier Long Humeral Nail | HSB | 264 | |
| K220914 | Tornier Perform Humeral System Fracture | PHX | 198 | |
| K220418 | Tornier Perform Humeral System Stemless | PKC | 212 | |
| K211359 | Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation | PHX | 193 | |
| K213124 | Tomier Perform Reversed Glenoid Cannulated Glenospheres | PHX | 29 | |
| K201315 | PERFORM Humeral System Stem | PAO | 116 | |
| K193247 | LATITUDE EV Total Elbow Arthroplasty | JDB | 254 |
Source: openFDA device/510k · retrieved
Where is Tornier, Inc. registered?
FDA lists 3 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Tornier, Inc. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.