Conformis, Inc.
1054 adverse events · 51 clearances · 34 recalls · 9 inspections · 1 compliance actions
Scorecard
Events per device across the 1,885-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0.002 →
4 in the last 12 months
Higher volume than 85% of companies with 10+ devices
Recalls per device
0 →
0 in the last 12 months
Higher volume than 97% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
1,885 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| iTotal® PS | TPS111111102 | JWH OIY OOG | M572TPS1111111021 | 462 |
| iTotal® Cruciate Retaining (CR) Knee Replacement System | TCR111111102 | JWH OOG | M572TCR1111111021 | 419 |
| iTotal PS | TPS-111-111101 | JWH OIY OOG | M572TPS1111111011 | 232 |
| iTotal® Cruciate Retaining (CR) Knee Replacement System | TCR121111102 | JWH OIY OOG | M572TCR1211111021 | 170 |
| iTotal® Identity Cruciate Retaining Knee Replacement System | TCR101111201 | JWH OIY OOG | M572TCR1011112011 | 137 |
| iTotal® Posterior Stabilized (PS) Knee Replacement System | TPS121111102 | JWH OIY OOG | M572TPS1211111021 | 82 |
| iTotal Identity CR | TCR-101-111211 | JWH OIY OOG | M572TCR1011112111 | 69 |
| iTotal Identity Posterior Stabilized Knee Replacement System | TPS101111201 | JWH OIY OOG | M572TPS1011112011 | 69 |
| iTotal® Hip Replacement System | HBS033000001 | LPH LZO MEH OQG | M572HBS0330000011 | 63 |
| iTotal Identity PS | TPS-101-111211 | JWH OIY OOG | M572TPS1011112111 | 57 |
| iUni iPoly Implant | UKA-111-111103 | HSX OOG | M572UKA1111111031 | 21 |
| ITOTAL IDENTITY IMPACTOR HANDLE | 1080-212 | LXH | 00810933030582 | 18 |
| iDuo | BKA-111-111102 | NPJ | M572BKA1111111021 | 15 |
| iTotal® Hip Replacement System | HCC032000001 | LPH LZO MEH OQG | M572HCC0320000011 | 15 |
| Identity Imprint Knee Replacement System | TPS000D00201 | JWH OIY OOG | M572TPS000D002011 | 9 |
| iTotal® Cruciate Retaining (CR) Knee Replacement System | TCR111SPEC02 | JWH OOG | M572TCR111SPEC021 | 8 |
| iTotal Identity Posterior Stabilized Knee Replacement System | TPS000D00101 | JWH OIY OOG | M572TPS000D001011 | 7 |
| iTotal® Identity Cruciate Retaining Knee Replacement System | TCR000D00101 | JWH OIY OOG | M572TCR000D001011 | 6 |
| iTotal PS Knee Replacement System | RPS010220012 | JWH OIY OOG | M572RPS0102200121 | 5 |
| iTotal® Cruciate Retaining (CR) Knee Replacement System | TCR121SPEC02 | JWH OOG | M572TCR121SPEC021 | 5 |
| iTotal® Cruciate Retaining (CR) Knee Replacement System | TCR111111101 | JWH OOG | M572TCR1111111011 | 5 |
| iTotal® Identity Cruciate Retaining Knee Replacement System | TCR301111301 | JWH OIY OOG | M572TCR3011113011 | 5 |
| iTotal® PS Tibial Keel Punch Tip | 1080-550 | JWH | 00850268007460 | 5 |
| iTotal® PS Tibial Keel Punch Tip | 1080-551 | JWH | 00850268007477 | 5 |
| iTotal® PS Tibial Keel Punch Tip | 1080-552 | JWH | 00850268007484 | 5 |
| iTotal® PS iPoly® Insert Kit | RPS010170001 | JWH OOG | M572RPS0101700011 | 5 |
| iTotal® PS iPoly® Insert Kit | RPS010150001 | JWH OOG | M572RPS0101500011 | 5 |
| iTotal® PS iPoly® Insert Kit | RPS010210001 | JWH OOG | M572RPS0102100011 | 5 |
| iTotal® PS iPoly® Insert Kit | RPS010190001 | JWH OOG | M572RPS0101900011 | 5 |
| iTotal® PS iPoly® Insert Kit | RPS010200001 | JWH OOG | M572RPS0102000011 | 5 |
Showing 1–30 of 1,885Next →
Compliance actions
FDA warning letters and enforcement actions (full history).
| Date | Type | Action | Firm |
|---|---|---|---|
| 2019-12-10 | WL | Warning Letter | Conformis Inc. |
Facilities
Registered establishments with their latest FDA inspection outcome.
No registered facilities linked.