Cleared Traditional

K831851 - STRAIGHT STEM FEMORAL HEAD PROSTHESIS

K831851 is an FDA 510(k) clearance for STRAIGHT STEM FEMORAL HEAD PROSTHESIS, manufactured by Proteck, Inc.. The device is a Class 2 Orthopedic device with product code KWL cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K831851 · Proteck, Inc. · Orthopedic device
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Oct 1983
Decision
119d
Days
Class 2
Risk

K831851 is an FDA 510(k) clearance for the STRAIGHT STEM FEMORAL HEAD PROSTHESIS. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal (product code KWL), Class II - Special Controls.

Submitted by Proteck, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 6, 1983 after a review of 119 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K831851

510(k) Number K831851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1983
Decision Date October 06, 1983
Days to Decision 119 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 122d · This submission: 119d
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 99
Devices cleared under the same product code (KWL) and FDA review panel - the closest regulatory comparables to K831851.
PENNSYLVANIA HOSPITAL HIP SYS
K841437 · Biomet, Inc. · Jun 1984
MODIFIED HPS HIP PROSTHESIS
K833599 · Depuy, Inc. · Mar 1984
BDH UNIPOLAR FEMORAL COMPONENT A2
K833403 · Carbomedics, Inc. · Jan 1984
AUFRANC-TURNER ATS TOTAL HIP SYSTEM
K830307 · Howmedica Corp. · Mar 1983
METAL KNEE & HIP PROSTHESIS
K823051 · Zimmer, Inc. · Dec 1982
IOI 32 TM FEMORAL COMPONENT
K822321 · Intermedics Orthopedics · Aug 1982
K831851 · STRAIGHT STEM FEMORAL HEAD PROSTHESIS
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