Medical device manufacturer
Howmedica Osteonics Corp.
Howmedica Osteonics Corp. holds 335 FDA 510(k) clearances across 49 product codes. Median elapsed review time is 59 days. openFDA lists 237 recall records naming the company. FDA publishes it under 11 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 335
- Product codes
- 49
- Median review
- 59 days
- Recall records
- 237
How does FDA spell Howmedica Osteonics Corp.?
FDA publishes this company under 11 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 |
|---|---|---|
| HOWMEDICA OSTEONICS CORP | device/registrationlisting | normalised |
| Howmedica Osteonics | device/510k | normalised |
| Howmedica Osteonics Corp | device/recall | normalised |
| Howmedica Osteonics Corp (Dba Stryker Orthopaedics) | device/510k | normalised |
| Howmedica Osteonics Corp dba Stryker Craniomaxillofacial | device/recall | normalised |
| Howmedica Osteonics Corp. | device/recall | normalised |
| Howmedica Osteonics Corp. | device/enforcement | normalised |
| Howmedica Osteonics Corp. | device/510k | normalised |
Showing 8 of 11.
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 Howmedica Osteonics Corp. file in?
49 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 39 | 28 days | |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 36 | 76 days | |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 27 | 53 days | |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 22 | 89 days | |
| HRS | Plate, Fixation, Bone | 21 | 51 days | |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 21 | 59 days | |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 19 | 55 days | |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 19 | 60 days | |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 13 | 86 days | |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 11 | 70 days | |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 10 | 30 days | |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | 9 | 36 days | |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 9 | 28 days | |
| KWP | Appliance, Fixation, Spinal Interlaminal | 7 | 30 days | |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 6 | 29 days | |
| HWC | Screw, Fixation, Bone | 5 | 23 days | |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | 5 | 36 days | |
| MNI | Orthosis, Spinal Pedicle Fixation | 5 | 45 days | |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 4 | 30 days | |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 4 | 33 days | |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | 4 | 104 days | |
| MQV | Filler, Bone Void, Calcium Compound | 3 | 90 days | |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 2 | 29 days | |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 2 | 72 days | |
| HTY | Pin, Fixation, Smooth | 2 | 60 days |
Showing the 25 they file in most, of 49.
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 Howmedica Osteonics Corp. had a recall?
openFDA lists 237 recall records naming this company across its whole history, of which 5 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-2461-2026Class IIOpen, ClassifiedMBH
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).
Z-2462-2026Class IIOpen, ClassifiedMBH
Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in packaging labeled as Triathlon Universal Baseplate Size 3, (lot UZD9IB).
Z-1572-2026Class IIOpen, ClassifiedOLO
A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.
Z-0963-2026Class IIOpen, ClassifiedHAW
When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.
Z-2640-2025Class IIOpen, ClassifiedJDI
a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
Showing the 5 most recently initiated of 237.
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 Howmedica Osteonics Corp. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component | LPH | 56 | |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert | MBH | 91 | |
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper | KRO | 95 | |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | MBH | 116 | |
| K251665 | Triathlon® Hinge Knee System | KRO | 56 | |
| K250989 | Stryker and Serf hip devices | LPH | 116 | |
| K243817 | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert Posteriorly Stabilized Insert | JWH | 56 | |
| K243784 | Stryker Orthopaedics Hip Devices Labeling Update | LPH | 59 | |
| K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System | JWH | 76 | |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component | JDI | 49 |
Source: openFDA device/510k · retrieved
Where is Howmedica Osteonics Corp. registered?
FDA lists 1 registered establishment 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 Howmedica Osteonics Corp. files next
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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.