OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY— 510(k) K023186

Clearance details

Applicant

Exactech, Inc.

Product code

Code JWH

Device class

Class 2

Regulation

21 CFR 888.3560

Advisory panel

Orthopedic

Date received

2002-09-24

Decision date

2002-10-17

Decision

Substantially Equivalent

Clearance type

Special

Location

Gainesville, FL, US

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• K262130 — ATTUNE Revision Knee System2026-09-04

• K260583 — Equinoxe® Shoulder System2026-04-14
• K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants2025-12-01
• K243448 — Equinoxe® Shoulder System2025-08-01
• K243275 — Equinoxe® Scapula Fracture System2025-06-26
• K243839 — Alteon® HA Femoral Stems2025-03-10

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-0126-2018 — Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX.Class II·Terminated·Exactech, Inc.·20170919
• Z-0127-2018 — Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX.Class II·Terminated·Exactech, Inc.·20170919
• Z-0128-2018 — Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX.Class II·Terminated·Exactech, Inc.·20170919
• Z-0129-2018 — Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.Class II·Terminated·Exactech, Inc.·20170919
• Z-0130-2018 — Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14, Sterile, RX.Class II·Terminated·Exactech, Inc.·20170919
• Z-0131-2018 — Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX.Class II·Terminated·Exactech, Inc.·20170919
• Z-0132-2018 — Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.Class II·Terminated·Exactech, Inc.·20170919
• Z-0133-2018 — Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha, Ref 208-04-23, Sterile, RX.Class II·Terminated·Exactech, Inc.·20170919
• Z-0134-2018 — Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-24, Sterile, RX.Class II·Terminated·Exactech, Inc.·20170919
• Z-0135-2018 — Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.Class II·Terminated·Exactech, Inc.·20170919
• Z-0136-2018 — Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX.Class II·Terminated·Exactech, Inc.·20170919
• Z-0137-2018 — Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Sterile, RX.Class II·Terminated·Exactech, Inc.·20170919
• Z-0138-2018 — Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX.Class II·Terminated·Exactech, Inc.·20170919
• Z-0139-2018 — Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile, RX.Class II·Terminated·Exactech, Inc.·20170919
• Z-0140-2018 — Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Sterile, RX.Class II·Terminated·Exactech, Inc.·20170919
• Z-0141-2018 — Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .Class II·Terminated·Exactech, Inc.·20170919
• Z-0142-2018 — Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.Class II·Terminated·Exactech, Inc.·20170919
• Z-0143-2018 — Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX.Class II·Terminated·Exactech, Inc.·20170919
• Z-0144-2018 — Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53, Sterile, RX.Class II·Terminated·Exactech, Inc.·20170919
• Z-0145-2018 — Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.Class II·Terminated·Exactech, Inc.·20170919

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K023186.