Cleared Traditional

K883969 - UNI-KNEE COMPONENT OF THE NATURAL-KNEE ...

K883969 is an FDA 510(k) clearance for UNI-KNEE COMPONENT OF THE NATURAL-KNEE ..., manufactured by Intermedics Orthopedics. The device is a Class 2 Orthopedic device with product code HRY cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K883969 · Intermedics Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1989
Decision
211d
Days
Class 2
Risk

K883969 is an FDA 510(k) clearance for the UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer (product code HRY), Class II - Special Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on April 19, 1989 after a review of 211 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3530 - 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 - K883969

510(k) Number K883969 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received September 20, 1988
Decision Date April 19, 1989
Days to Decision 211 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
89d slower than avg
Panel avg: 122d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRY Device Classification - Class 2, Special Controls

Product Code HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3530
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 - HRY Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

All 75
Devices cleared under the same product code (HRY) and FDA review panel - the closest regulatory comparables to K883969.
OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP
K911373 · Osteonics Corp. · Jun 1991
WHITESIDE ORTHOLOC MODULAR TIBIAL AUGMENTATION
K902538 · Dow Corning Wright · Jul 1990
BIOPRO ANATOMIC UNICOMPARTMENTAL KNEE
K890044 · Biopro, Inc. · Nov 1989
KINEMAX TIBIAL WEDGE
K884837 · Howmedica Corp. · Feb 1989
KIRSCHNER (R) UNICONDYLAR-II KNEE SYSTEM
K882241 · Kirschner Medical Corp. · Jun 1988
AGC UNICOMPARTMENTAL KNEE PROSTHESIS
K873601 · Biomet, Inc. · Jan 1988