MOST OPTIONS SYSTEM— 510(k) K013031

Name: FDA 510(k) clearance K013031
Creator: U.S. Food and Drug Administration
Published: 2001-12-07

Substantially Equivalent

Sulzer Orthopedics, Inc.

FDA 510(k) clearance K013031 for MOST OPTIONS SYSTEM, Substantially Equivalent on 2001-12-07. Applicant: Sulzer Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Sulzer Orthopedics, Inc.
Product code: Code KRO
Device class: Class 2
Regulation: 21 CFR 888.3510
Advisory panel: Orthopedic
Date received: 2001-09-10
Decision date: 2001-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRO

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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

More clearances from Sulzer Orthopedics, Inc.

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K022985 — ASCENDENT ACETABULAR SYSTEM2002-12-05
K021578 — NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE2002-08-09
K020713 — MS-30 LATERAL FEMORAL STEM2002-05-14
K013935 — ALLOFIT ACETABULAR SYSTEM 32MM ALPHA DURASUL INSERTS2001-12-13
K012739 — CONVERGE ACETABULAR SYSTEM2001-11-14

Adverse events under product code KRO

product code KRO

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 →

Recalls naming K013031

K-number listed on FDA's recall record

Z-1250-2014 — MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6MM M HINGED TIB INS SZ 4 9MM M HINGED TIB INS SZ 4 16MM MOST PROX TIB INS 6MMClass II·Terminated·Zimmer, Inc.·20140225

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K013031.

Data sourced from openFDA. This site is unofficial and independent of the FDA.