Cleared Traditional

COLLARLESS TAPERED STEM HIP PROSTH. DEV (K811738) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K811738 · Biomet, Inc. · Orthopedic device
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Jul 1981
Decision
31d
Days
Class 2
Risk

K811738 is an FDA 510(k) clearance for the COLLARLESS TAPERED STEM HIP PROSTH. DEV. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Biomet, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1981 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomet, Inc. devices

Submission Details

510(k) Number K811738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1981
Decision Date July 20, 1981
Days to Decision 31 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 122d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWL Prosthesis, Hip, Hemi-, Femoral, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - KWL Prosthesis, Hip, Hemi-, Femoral, Metal

All 49
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K811738.
AUFRANC-TURNER ATS TOTAL HIP SYSTEM
K830307 · Howmedica Corp. · Mar 1983
METAL KNEE & HIP PROSTHESIS
K823051 · Zimmer, Inc. · Dec 1982
MOORE HIP PROSTHESIS, PMMA COATED
K811416 · Zimmer, Inc. · Aug 1981
PROSTHESIS, HIP FEMORAL COMPONENT METAL
K803191 · Osteonics Corp. · Jan 1981
UHR UNIVERSAL6HIP REPLACEMENT
K800207 · Osteonics Corp. · Feb 1980
3M HS 22 FEMORAL COMPONENT
K792181 · 3M Company · Nov 1979