Cleared Traditional

K925242 - APOLLO(TM) KNEE SYSTEM

K925242 is an FDA 510(k) clearance for APOLLO(TM) KNEE SYSTEM, manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K925242 · Intermedics Orthopedics · Orthopedic device
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Jun 1993
Decision
231d
Days
Class 2
Risk

K925242 is an FDA 510(k) clearance for the APOLLO(TM) KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on June 4, 1993 after a review of 231 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 Intermedics Orthopedics devices

FDA 510(k) Submission Details - K925242

510(k) Number K925242 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 16, 1992
Decision Date June 04, 1993
Days to Decision 231 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
109d slower than avg
Panel avg: 122d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 787
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K925242.
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ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP
K930190 · Dow Corning Wright · Aug 1993
ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT
K921182 · Biomet, Inc. · Jul 1993
ORTHOLOC ADVANTIM THICK TIBIAL BASE COMPONENT
K926257 · Dow Corning Wright · May 1993
WHITESIDE ORTHOLOC(R) MODULAR REVISION FEMOR COMP
K915525 · Dow Corning Wright · May 1993
NATURAL-KNEE ALL-POLY TIBIA
K923443 · Intermedics Orthopedics · Mar 1993