Medical device manufacturer
Intermedics Orthopedics
Intermedics Orthopedics holds 108 FDA 510(k) clearances across 28 product codes. Median elapsed review time is 90 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 108
- Product codes
- 28
- Median review
- 90 days
- Recall records
- 0
How does FDA spell Intermedics Orthopedics?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Intermedics Orthopedics file in?
28 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 21 | 91 days | |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 19 | 230 days | |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 17 | 99 days | |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 5 | 59 days | |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 5 | 100 days | |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 4 | 119 days | |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 3 | 79 days | |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 3 | 64 days | |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 3 | 17 days | |
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 3 | 76 days | |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 3 | 82 days | |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 3 | 66 days | |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 2 | 25 days | |
| JDQ | Cerclage, Fixation | 2 | 61 days | |
| FYE | Dress, Surgical | 1 | 71 days | |
| GFA | Blade, Saw, General & Plastic Surgery, Surgical | 1 | 253 days | |
| HRS | Plate, Fixation, Bone | 1 | 184 days | |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 1 | 71 days | |
| HSZ | Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment | 1 | 27 days | |
| HTP | File | 1 | 294 days | |
| HWC | Screw, Fixation, Bone | 1 | 53 days | |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 | 321 days | |
| JDJ | Mesh, Surgical, Acetabular, Hip, Prosthesis | 1 | 191 days | |
| JOL | Catheter And Tip, Suction | 1 | 16 days | |
| KMC | Prosthesis, Hip, Semi-Constrained, Composite/Metal | 1 | 92 days |
Showing the 25 they file in most, of 28.
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 Intermedics Orthopedics 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 Intermedics Orthopedics cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K970300 | NATURAL-HIP SYSTEM POROUS STEM WITH HA/CSTI | LPH | 160 | |
| K970498 | NATURAL-KNEE II REVISION FEMORAL SPACER LUGS | JWH | 79 | |
| K970166 | NATURAL-HIP SYSTEM COCR REVISION STEM | LZO | 82 | |
| K970567 | SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS | KWT | 14 | |
| K964357 | NATURAL-HIP SYSTEM COCR STEM | LZO | 87 | |
| K964350 | MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA | JDI | 77 | |
| K962190 | PATELLOFEMORAL JOINT PROSTHESIS | KRR | 144 | |
| K963266 | NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED | LPH | 56 | |
| K963155 | INTERMOORE FRACTURE HIP STEM (MODIFY) | LWJ | 57 | |
| K962315 | SELECT SHOULDER COCR HUMERAL STEM COMPONENT | KWT | 78 |
Source: openFDA device/510k · retrieved
Watch what Intermedics Orthopedics 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.