510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K140900Substantially Equivalent

Patient Specific Smiles Total Knee Replacement

Stanmore Worldwide Implants, Ltd., Plymouth MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140900 is the FDA 510(k) clearance record for PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT, a class II device, cleared for Stanmore Worldwide Implants , Ltd. on under FDA product code KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer). FDA records list one 510(k) clearance for Stanmore Worldwide Implants , Ltd. As of , FDA records show no recalls naming K140900.

Clearance record

Decision date
Received
(310 days to decision)
Product code
KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Regulation
21 CFR 888.3510
Device class
Class II
Review panel
Orthopedic
Applicant
Stanmore Worldwide Implants , Ltd. 10 Cordage Rd. Park Cir., Suite 200, Plymouth MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KRO

Trailing 12 months
2 clearances under product code KRO in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KRO, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260