Cleared Traditional

K823051 - METAL KNEE & HIP PROSTHESIS

K823051 is an FDA 510(k) clearance for METAL KNEE & HIP PROSTHESIS, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code KWL cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K823051 · Zimmer, Inc. · Orthopedic device
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Dec 1982
Decision
46d
Days
Class 2
Risk

K823051 is an FDA 510(k) clearance for the METAL KNEE & HIP PROSTHESIS. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Zimmer, Inc. (Walker, US). The FDA issued a Cleared decision on December 3, 1982 after a review of 46 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K823051

510(k) Number K823051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1982
Decision Date December 03, 1982
Days to Decision 46 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 122d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWL Device Classification - Class 2, Special Controls

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 81
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K823051.
PENNSYLVANIA HOSPITAL HIP SYS
K841437 · Biomet, Inc. · Jun 1984
MODIFIED HPS HIP PROSTHESIS
K833599 · Depuy, Inc. · Mar 1984
AUFRANC-TURNER ATS TOTAL HIP SYSTEM
K830307 · Howmedica Corp. · Mar 1983
IOI 32 TM FEMORAL COMPONENT
K822321 · Intermedics Orthopedics · Aug 1982
KAMPNER FEMORAL COMPONENT
K822320 · Intermedics Orthopedics · Aug 1982
BDH FEMORAL COMPONENT
K821343 · Intermedics Orthopedics · Jun 1982