PATIENT SPECIFIC DISTAL FEMORAL— 510(k) K140898

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

2014-04-08

Decision date

2015-01-20

Decision

Substantially Equivalent

Clearance type

Special

Location

Plymouth, 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

• 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
• K121055 — METS MODULAR TOTAL 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-1778-2022 — Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.Class II·Ongoing·Howmedica Osteonics Corp.·20220824
• Z-3104-2017 — JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in the distal femur.Class II·Terminated·Stanmore Implants Worldwide Ltd.·20170704

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K140898.