Cleared Traditional

K972967 - OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT

Also marketed or referenced as:
OSTEONICS SCORPIO TOTAL KNEE RECESSED PATELLAR COMPONENT

K972967 is an FDA 510(k) clearance for OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL ..., manufactured by Osteonics Corp.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K972967 · Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
158d
Days
Class 2
Risk

K972967 is an FDA 510(k) clearance for the OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on January 16, 1998 after a review of 158 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 Osteonics Corp. devices

FDA 510(k) Submission Details - K972967

510(k) Number K972967 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 11, 1997
Decision Date January 16, 1998
Days to Decision 158 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
36d slower than avg
Panel avg: 122d · This submission: 158d
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 893
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K972967.
OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM
K974556 · Osteonics Corp. · Feb 1998
ADVANCE TOTAL KNEE SYSTEM
K974328 · Wrightmedicaltechnologyinc · Jan 1998
DEPUY AMK 3 PEG PATELLA
K972643 · Depuy, Inc. · Jan 1998
THE POSTERIOR STABILISED NUFFIELD TOTAL KNEE SYSTEM
K973595 · Corin USA · Dec 1997
FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA
K973672 · Encore Orthopedics, Inc. · Dec 1997
ADVANCE MODULAR TIBIAL COMPONENT
K973524 · Wrightmedicaltechnologyinc · Dec 1997