Cleared Traditional

K930712 - P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR

K930712 is an FDA 510(k) clearance for P.F.C. TOTAL HIP SYSTEM POROUS COATED M..., manufactured by Johnson & Johnson Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K930712 · Johnson & Johnson Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1993
Decision
235d
Days
Class 2
Risk

K930712 is an FDA 510(k) clearance for the P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Johnson & Johnson Orthopaedics, Inc. (Raynham, US). The FDA issued a Cleared decision on October 4, 1993 after a review of 235 days - an extended review cycle.

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. 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.

View all Johnson & Johnson Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K930712

510(k) Number K930712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1993
Decision Date October 04, 1993
Days to Decision 235 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 122d · This submission: 235d
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 K930712.
P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET
K931189 · Johnson & Johnson Orthopaedics, Inc. · Feb 1994
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TOTAL HIP PROTHESIS FEMORAL COMPONENT
K923734 · Intermedics Orthopedics · Jun 1993