Cleared Traditional

K971770 - APOLLO KNEE FEMORAL SPACERS

K971770 is an FDA 510(k) clearance for APOLLO KNEE FEMORAL SPACERS, manufactured by Sulzer Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K971770 · Sulzer Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
79d
Days
Class 2
Risk

K971770 is an FDA 510(k) clearance for the APOLLO KNEE FEMORAL SPACERS. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Sulzer Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on July 31, 1997 after a review of 79 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sulzer Orthopedics, Inc. devices

FDA 510(k) Submission Details - K971770

510(k) Number K971770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1997
Decision Date July 31, 1997
Days to Decision 79 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
43d faster than avg
Panel avg: 122d · This submission: 79d
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 800
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K971770.
ADVANCE ULTRA-CONGRUENT TIBIAL INSERT
K972770 · Wrightmedicaltechnologyinc · Oct 1997
APOLLO REVISION/CONSTRAINED KNEE SYSTEM
K972501 · Sulzer Orthopedics, Inc. · Oct 1997
ADVANCE KNEE SYSTEM
K972626 · Wrightmedicaltechnologyinc · Sep 1997
IMPLEX CONTINUUM POROUS PATELLAR
K971789 · Implex Corp. · Jul 1997
P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)
K971189 · Johnson & Johnson Professionals, Inc. · Jul 1997
P.F.C. SIGMA INSET PATELLA
K971652 · Johnson & Johnson Professionals, Inc. · Jul 1997