Panels › Orthopedic › Product code HSX · Class 2
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Regulation 888.3520
3510(k)s in 12 months (115 all time)
0recalls in 12 months (104 all time)
100recalls that name a 510(k)
Top companies in HSX
| Company | 510(k)s | Recalls |
|---|---|---|
| Smith & Nephew, Inc. | 13 | 54 |
| Linkbio Corp. | 0 | 32 |
| Conformis, Inc. | 8 | 3 |
| Zimmer, Inc. | 9 | 2 |
| Bodycad Laboratories, Inc. | 7 | 0 |
| Mako Surgical Corp. | 6 | 0 |
| Zimmer Biomet | 1 | 5 |
| Depuy, Inc. | 5 | 0 |
| Howmedica Corp. | 5 | 0 |
| Medacta International S.A. | 5 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2023 | Smith & Nephew, Inc. Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers:
a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM;
b) REF 1-10013-110, SIZE 1-LEFT MED, 10MM;
c) REF 1-10013-111, SIZ Open, Classified |
HSX | K190439 |
| May 31, 2023 | Smith & Nephew, Inc. Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL;
b) REF 1-10012-150, SIZE 1-RIGHT MEDIAL;
c) REF 1-10012-200, SIZE 2-LEF Open, Classified |
HSX | K190439 |
| May 31, 2023 | Smith & Nephew, Inc. Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee Open, Classified |
HSX | K190439 |
| May 31, 2023 | Smith & Nephew, Inc. Smith&Nephew ENGAGE Cementless Partial Knee System, Porous Femoral components, Part Numbers:
a) REF 1-10003-100 (SIZE 1 Right Medial);
b) REF 1-10003-110 (SIZE 1 Left Medial);
c) REF 1-10003-200 Open, Classified |
HSX | K190439 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM
Item Number: 15-2030/15 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM
Item Number: 15-2030/14 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 8 MM X 45 MM
Item Number: 15-2030/13 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM
Item Number: 15-2030/12 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM
Item Number: 15-2030/11 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM
Item Number: 15-2030/10 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM
Item Number: 15-2030/08 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 11 MM X 50 MM
Item Number: 15-2030/07 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM
Item Number: 15-2030/06 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System
ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM
Item Number: 15-2030/04 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM
Item Number: 15-2030/03 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM
Item Number: 15-2030/02 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 13X58MM
Item Number: 15-2028/16 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 11X58MM
Item Number: 15-2028/15 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 9X58MM
Item Number: 15-2028/14 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 7MM X 58MM
Item Number: 15-2028/13 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 13MM X 55MM
Item Number: 15-2028/12 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 11MM X 55MM
Item Number: 15-2028/11 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 9MM X 55MM
Item Number: 15-2028/10 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 7MM X 55MM
Item Number: 15-2028/09 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 13MM X 50MM
Item Number: 15-2028/08 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 11MM X 50MM
Item Number: 15-2028/07 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 9MM X 50MM
Item Number: 15-2028/06 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 7MM X 50MM
Item Number: 15-2028/05 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 13MM X 45MM
Item Number: 15-2028/04 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 11MM X 45MM
Item Number: 15-2028/03 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 9MM X 45MM
Item Number: 15-2028/02 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ALL POLY TIBIAL COMPONENT 7MM X 45MM
Item Number: 15-2028/01 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ENDO SLED KNEE FEM COMP, Large
Item Number: 15-2020/60 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ENDO SLED KNEE FEM COMP, MEDIUM
Item Number: 15-2020/52 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ENDO SLED KNEE FEM COMP, MEDIUM SMALL
Item Number: 15-2020/46 Open, Classified |
HSX | K954186 |
| May 4, 2023 | Linkbio Corp. LINK SLED Knee System:
ENDO SLED KNEE FEM COMP, SMALL
Item Number: 15-2020/40 Open, Classified |
HSX | K954186 |
| Apr 14, 2023 | Smith & Nephew, Inc. JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM Open, Classified |
HSX | K190085 |
| Apr 12, 2023 | Howmedica Osteonics Corp. stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure Open, Classified |
HSX | K082172 K090763 |
| Apr 12, 2023 | Howmedica Osteonics Corp. stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure Open, Classified |
HSX | K082172 K090763 |
| Jun 19, 2020 | Encore Medical, LP EMPOWR Partial Knee Peg Drill; Model: 800-06-008. Open, Classified |
HSX | K191325 |
| Jun 19, 2020 | Encore Medical, LP EMPOWR Partial Knee Peg Drill Guide; Model: 800-06-007. Open, Classified |
HSX | K191325 |
| Jan 28, 2020 | Smith & Nephew, Inc. JOURNEY II UNI RESECTION PREP TRIAL, RIGHT MEDIAL/ LEFT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to asses Terminated |
HSX | K190085 |
| Jan 28, 2020 | Smith & Nephew, Inc. JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT LATERAL - Product Usage: The JOURNEY II Uni Resection Prep Trial is a reusable surgical instrument used during range of motion trialing to asses Terminated |
HSX | K190085 |
| Nov 29, 2017 | Zimmer Biomet, Inc. FEM PRC LT M/RT L SML
FEM PRC RT M/LT L SML
FEM PRC LT M/RT L SML+
FEM PRC RT M/LT L SML+
FEM PRC LT M/RT L REG
FEM PRC RT M/LT L REG
FEM PRC LT M/R Terminated |
HSX | K880155 K942263 |
| Nov 29, 2017 | Zimmer Biomet, Inc. ZUK PRC FEM SZB RMED/LLAT
ZUK PRC FEM SZC LMED/RLAT
ZUK PRC FEM SZC RMED/LLAT
NGU PRC FEM SZD LMED/RLAT
ZUK PRC FEM SZD RMED/LLAT
ZUK PRC FEM SZE LMED/RLAT
ZUK PRC FEM SZF RMED/LLAT
" These devices a Terminated |
HSX | K033363 |
| Nov 29, 2017 | Zimmer Biomet, Inc. Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model Number:42-5399-035-09; (3) 10mm block, Model Number: 42-5399-035-10; (4) 12mm block, Mo Terminated |
HSX | K161592 |
| Oct 3, 2017 | Arthrex, Inc. iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL
Indicated for use in uni-compartmental knee arthroplasty as Terminated |
HSX | K060670 |
| Jul 5, 2017 | Zimmer Biomet, Inc. Persona Partial Knee System, Size 8, Finishing Guide Terminated |
HSX | K161592 |
| Feb 22, 2016 | Zimmer Biomet, Inc. ZIMMER UNI HIGH FLEX PRECOAT FEM
prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer
various sizes
These devices are indicated for patients with: - Painful and/or disabling knee Terminated |
HSX | K033363 |
| Jun 27, 2014 | Blue Belt Technologies MN Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis. Terminated |
HSX | K123380 |
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