510(k) K061223 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
ADVANCE TOTAL KNEE SYSTEM
| Applicant | Wrightmedicaltechnologyinc, Arlington TN, US |
| Decision | Substantially Equivalent, Aug 18, 2006 |
| Received | May 2, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061223
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA10, SIZE 1 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, ST Terminated |
MBH | None listed |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA11, SIZE 1+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, STERI Terminated |
MBH | None listed |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA20, SIZE 2 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, ST Terminated |
MBH | None listed |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA21, SIZE 2+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERI Terminated |
MBH | None listed |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA30, SIZE 3 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, ST Terminated |
MBH | None listed |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA31, SIZE 3+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, STERI Terminated |
MBH | None listed |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA40, SIZE 4 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, ST Terminated |
MBH | None listed |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA41, SIZE 4+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, STERI Terminated |
MBH | None listed |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA50, SIZE 5 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, ST Terminated |
MBH | None listed |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA51, SIZE 5+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, STERI Terminated |
MBH | None listed |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 6 FEMUR & SIZE 6 TIBIAL INSERT; CONTENTS, 1 EACH, ST Terminated |
MBH | None listed |
| Dec 8, 2009 | Wright Medical Technology Inc ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-0140, DIAMETER 11mm, LENGTH 140mm, 1 EACH, STERILE R, (FOR USE WITH CEMENT ONLY), SINGLE USE ONLY, (Ti6A14V), Wright Medical Technology, Inc., 5677 Terminated |
MBH | None listed |
| Dec 8, 2009 | Wright Medical Technology Inc ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-2140, DIAMETER 13mm, LENGTH 140mm, 1 EACH, STERILE R, (FOR USE WITH CEMENT ONLY), SINGLE USE ONLY, (Ti6A14V), Wright Medical Technology, Inc., 5677 Terminated |
MBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.