510(k) K102795 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
SIGNATURE PLANNER; SIGNATURE GUIDES
| Applicant | Materialise NV, Leuven, BE |
| Decision | Substantially Equivalent, Feb 2, 2011 |
| Received | Sep 27, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102795
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 3, 2016 | Materialise USA LLC Signature TKA GDE/MDL Set 04-05
Patient-specific surgical guide and instrument set. Terminated |
JWH | None listed |
| Oct 23, 2015 | Materialise N.V. Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient C Terminated |
OSF | None listed |
| Mar 17, 2015 | Materialise N.V. Signature TKA GDE/MDL Set 04-05 (Femur & Tibia)
The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be Terminated |
JWH | None listed |
| Mar 2, 2012 | Biomet, Inc. REF 42-422561 SIGNATURE QTY, 1 TKA GDE/MDL (Prosthesis, knee) SET 04-05 DGHUMPHR-NOV52LKA-J_K-00432022 SLIDEX DISTAL-MP/PREMIER TIBIAL CUSTOM-MADE DEVICE
Signature Personalized Patient Care System is Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.