Cleared Traditional

K972791 - ENCORE LINEAR HIP

K972791 is an FDA 510(k) clearance for ENCORE LINEAR HIP, manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K972791 · Encore Orthopedics, Inc. · Orthopedic device
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Jan 1998
Decision
168d
Days
Class 2
Risk

K972791 is an FDA 510(k) clearance for the ENCORE LINEAR HIP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on January 12, 1998 after a review of 168 days - an extended review cycle.

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. 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 Encore Orthopedics, Inc. devices

FDA 510(k) Submission Details - K972791

510(k) Number K972791 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 28, 1997
Decision Date January 12, 1998
Days to Decision 168 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
46d slower than avg
Panel avg: 122d · This submission: 168d
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 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K972791.
ARTICUL/EZE FEMORAL HEADS
K980513 · DePuy Orthopaedics, Inc. · Apr 1998
ULTIMA ACETABULAR ROOF REINFORCEMENT RING
K980286 · Johnson & Johnson Professionals, Inc. · Apr 1998
SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM
K974558 · Biomet, Inc. · Mar 1998
FOUNDATION FRACTURE STEM
K973809 · Encore Orthopedics, Inc. · Jan 1998
DISTAL CENTRALIZER, EXETER II HIP SYSTEM
K974054 · Howmedica, Inc. · Dec 1997
TORNIER CEMENT RESTRICTOR
K973453 · Tornier · Dec 1997