Cleared Traditional

PROXIMAL INTERPHALANGEAL JOINT IMPLANT (K802342) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K802342 · Sutter Biomedical, Inc. · Orthopedic device
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Oct 1981
Decision
383d
Days
Class 2
Risk

K802342 is an FDA 510(k) clearance for the PROXIMAL INTERPHALANGEAL JOINT IMPLANT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Sutter Biomedical, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 14, 1981 after a review of 383 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sutter Biomedical, Inc. devices

Submission Details

510(k) Number K802342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1980
Decision Date October 14, 1981
Days to Decision 383 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
261d slower than avg
Panel avg: 122d · This submission: 383d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 282
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K802342.
CONTOUR II LINK SP TOTAL HIP PROSTHESIS
K821066 · C.R. Bard, Inc. · Apr 1982
CEMENT RING
K813089 · Biomet, Inc. · Nov 1981
HIP STEM SYSTEM TITANIUM ALLOY
K812801 · Osteonics Corp. · Oct 1981
MIAMI, PROTRUSIO RING
K812182 · Zimmer, Inc. · Aug 1981
EFTEKHAR CENTRALIZING PLUG
K811293 · Zimmer, Inc. · Jun 1981
COLLARLESS TOTAL HIP FEMORAL COMP. SYS
K811151 · Howmedica Corp. · May 1981