Medical device manufacturer
Howmedica Corp.
Howmedica Corp. holds 409 FDA 510(k) clearances across 80 product codes. Median elapsed review time is 77 days. openFDA lists no recall records naming the company. FDA publishes it under 2 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 409
- Product codes
- 80
- Median review
- 77 days
- Recall records
- 0
How does FDA spell Howmedica Corp.?
FDA publishes this company under 2 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 Corp. | device/510k | normalised |
| Howmedica, 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 Howmedica Corp. file in?
80 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 47 | 92 days | |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 43 | 91 days | |
| HRS | Plate, Fixation, Bone | 27 | 86 days | |
| HSB | Rod, Fixation, Intramedullary And Accessories | 26 | 72 days | |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 22 | 83 days | |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 19 | 94 days | |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 18 | 92 days | |
| JEC | Component, Traction, Invasive | 13 | 61 days | |
| HWC | Screw, Fixation, Bone | 12 | 90 days | |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 11 | 24 days | |
| EJS | Alloy, Other Noble Metal | 10 | 22 days | |
| EXB | Collector, Ostomy | 9 | 23 days | |
| JDQ | Cerclage, Fixation | 8 | 65 days | |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 7 | 26 days | |
| JEY | Plate, Bone | 6 | 88 days | |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 5 | 109 days | |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 5 | 94 days | |
| JDR | Staple, Fixation, Bone | 5 | 61 days | |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 5 | 77 days | |
| LZN | Cement Obturator | 5 | 25 days | |
| JDS | Nail, Fixation, Bone | 4 | 105 days | |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 4 | 21 days | |
| DXQ | Blood Pressure Cuff | 3 | 17 days | |
| EJT | Alloy, Gold-Based Noble Metal | 3 | 36 days | |
| EZR | Cement, Stomal Appliance, Ostomy | 3 | 69 days |
Showing the 25 they file in most, of 80.
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 Corp. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
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 Corp. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K984251 | XIA SPINE SYSTEM | KWQ | 89 | |
| K984202 | HOWMEDICA HUMERAL INTERCALARY SYSTEM | HSD | 73 | |
| K984305 | ZETA MULTIZONE LOCKING NAIL SYSTEM | HSB | 61 | |
| K983885 | BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES | JEY | 88 | |
| K983528 | MICRO DYNAMIC MESH | JEY | 76 | |
| K983404 | TYPE 3 FEMORAL COMPONENTS | LZO | 85 | |
| K980926 | DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION | JDI | 280 | |
| K980925 | DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION | JWH | 280 | |
| K980632 | DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION | JWH | 295 | |
| K980626 | DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION | JDI | 296 |
Source: openFDA device/510k · retrieved
Watch what Howmedica 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.