Cleared Traditional

K896851 - PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC

K896851 is an FDA 510(k) clearance for PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE..., manufactured by Lima Intl. Corp.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 392-day FDA review.

K896851 · Lima Intl. Corp. · Orthopedic device
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Jan 1991
Decision
392d
Days
Class 2
Risk

K896851 is an FDA 510(k) clearance for the PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Lima Intl. Corp. (E Providence, US). The FDA issued a Cleared decision on January 1, 1991 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Lima Intl. Corp. devices

FDA 510(k) Submission Details - K896851

510(k) Number K896851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1989
Decision Date January 01, 1991
Days to Decision 392 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
270d slower than avg
Panel avg: 122d · This submission: 392d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDI Device Classification - Class 2, Special Controls

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 526
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K896851.
BIOPRO TRINITY ACETABULAR CUP
K904207 · Biopro, Inc. · Jan 1991
OSTEONICS(R) 6011 HIP STEM SERIES
K905158 · Osteonics Corp. · Jan 1991
OSTEONICS HIP REVISION WEDGES
K905406 · Osteonics Corp. · Jan 1991
PRECISION HIP STEM WITH ADDITIONAL STEM SIZES
K904844 · Howmedica Corp. · Dec 1990
PROXIMAL FEMUR REPLACEMENT STEM
K904919 · Depuy, Inc. · Dec 1990
VSP HIP STEM
K903957 · Turnkey Intergration USA, Inc. · Nov 1990