METS SMILES TOTAL KNEE REPLACEMENT— 510(k) K120992

Clearance details

Applicant

Stanmore Implants Worldwide , Ltd.

Product code

Code KRO

Device class

Class 2

Regulation

21 CFR 888.3510

Advisory panel

Orthopedic

Date received

2012-04-02

Decision date

2012-09-05

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Canton, MA, US

• K261898 — Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System2026-08-06
• K252898 — Triathlon® Tritanium® Asymmetric Patella +5 more2025-12-15
• K252303 — Stem Extension Line (USTAR II System)2025-08-22
• K251665 — Triathlon® Hinge Knee System2025-07-25
• K242871 — ATTUNE Revision Hinge Knee2024-11-21

• K140898 — PATIENT SPECIFIC DISTAL FEMORAL2015-01-20
• K133152 — JTS EXTENDIBLE DISTAL FEMORAL IMPLANT2014-01-22
• K121765 — SCULPTOR ROBOTIC GUIDANCE ARM (RGA)2013-01-11
• K121056 — METS MODULAR PROXIMAL FEMUR2012-09-20
• K121029 — METS MODULAR DISTAL FEMUR2012-09-19

Death

19

Injury

4,841

Total

4,860

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-0820-2017 — Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur boneClass II·Terminated·Stanmore Implants Worldwide Ltd.·20161207
• Z-0821-2017 — Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small Short; Tibial Component Metal Cased Std Long; Tibial Component Metal Cased Std Short The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur boneClass II·Terminated·Stanmore Implants Worldwide Ltd.·20161207
• Z-0822-2017 — Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur boneClass II·Terminated·Stanmore Implants Worldwide Ltd.·20161207
• Z-0823-2017 — Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Stem 15x30 HA Coated; Femoral Integral Shaft & Stem 30x27 HA Coated; Femoral Integral Shaft & Stem 30x30 HA Coated The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur boneClass II·Terminated·Stanmore Implants Worldwide Ltd.·20161207
• Z-0824-2017 — DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem 15x36x44; DF Coated Integral Shaft & Stem 30x30x38; DF Coated Integral Shaft & Stem 30x36x44 The product is a component is a systems that is intended for the replacement if diseased or deficient bone around the knee joint, distal femur, proximal femur or total femur boneClass II·Terminated·Stanmore Implants Worldwide Ltd.·20161207
• Z-2553-2016 — METS SMILES Total Knee ReplacementClass II·Terminated·Stanmore Implants Worldwide Ltd.·20160531

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120992.