VANGUARD COMPLETE KNEE SYSTEM— 510(k) K113550

Clearance details

Applicant

Biomet Manufacturing Corp

Product code

Code JWH

Device class

Class 2

Regulation

21 CFR 888.3560

Advisory panel

Orthopedic

Date received

2011-12-01

Decision date

2012-02-29

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Warsaw, IN, US

• K260063 — GSPE Spacer2026-09-11
• K262293 — EVOLUTION MPX Total Knee System2026-09-10
• K262341 — b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions2026-09-08
• K262130 — ATTUNE Revision Knee System2026-09-04
• K253961 — SK Knee System2026-09-01

• K230540 — Patient Specific Planning Solution 3D Bone Models2023-07-25
• K214001 — Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System2023-03-15
• K211729 — Comprehensive® Convertible Glenoid - Vivacit-E Liner2021-11-04
• K202232 — Comprehensive Vault Reconstruction System2021-02-19
• K193038 — Comprehensive Shoulder System2020-10-28

Death

26

Injury

51,564

Malfunction

9,725

Other

9

Total

61,324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1042-2023 — (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item Number: 183108 (4) Vanguard Knee System PS Open Box Femoral; Right; 67.5 mm Item Number: 183110 (5) Vanguard Knee System PS Open Box Femoral; Right; 70 mm Item Number: 183112Class II·Ongoing·Biomet, Inc.·20221229
• Z-1043-2023 — (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPANDED RECALL: (2) Vanguard Knee System PS Open Box Femoral; Left; 60 mm. Item Number: 183124 (3) Vanguard Knee System PS Open Box Femoral; Left; 62.5 mm. Item Number: 183126Class II·Ongoing·Biomet, Inc.·20221229
• Z-0495-2019 — Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm Item Number: 183126Class II·Terminated·Zimmer Biomet, Inc.·20181022
• Z-0496-2019 — Vanguard Knee System -PS Open Box Femoral Right, 65 mm Item Number:183108Class II·Terminated·Zimmer Biomet, Inc.·20181022
• Z-2289-2018 — Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The product is intended for use in knee joint replacement arthroplasties.Class II·Terminated·Zimmer Biomet, Inc.·20180524
• Z-2183-2018 — Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.Class II·Terminated·Zimmer Biomet, Inc.·20180511
• Z-1011-2018 — Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in total knee arthroplastyClass II·Terminated·Zimmer Biomet, Inc.·20171003

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113550.