Cleared Traditional

K931571 - LINK CERAMIC HEADS 12/14 X 32MM

K931571 is an FDA 510(k) clearance for LINK CERAMIC HEADS 12/14 X 32MM, manufactured by Link America, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K931571 · Link America, Inc. · Orthopedic device
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Apr 1994
Decision
385d
Days
Class 2
Risk

K931571 is an FDA 510(k) clearance for the LINK CERAMIC HEADS 12/14 X 32MM. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Link America, Inc. (Denville, US). The FDA issued a Cleared decision on April 19, 1994 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Link America, Inc. devices

FDA 510(k) Submission Details - K931571

510(k) Number K931571 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 30, 1993
Decision Date April 19, 1994
Days to Decision 385 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
263d slower than avg
Panel avg: 122d · This submission: 385d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 476
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K931571.
SLT FEMORAL HEAD
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K933499 · U.S. Medical Products, Inc. · May 1994
KIRSCHNER ZIRCONIA FEMORAL HEAD
K934694 · Kirschner Medical Corp. · May 1994
APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-POLY ACET COMP
K933203 · Intermedics Orthopedics · Apr 1994
KINAMED REALITY TOTAL HIP SYSTEM
K922247 · Kinamed, Inc. · Mar 1994
TECHMEDICA CONTINUUM HIP SYSTEM
K931929 · Techmedica, Inc. · Mar 1994