Cleared Traditional

K802342 - PROXIMAL INTERPHALANGEAL JOINT IMPLANT

K802342 is an FDA 510(k) clearance for PROXIMAL INTERPHALANGEAL JOINT IMPLANT, manufactured by Sutter Biomedical, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 383-day FDA review.

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

FDA 510(k) Submission Details - K802342

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.

JDI Device Classification - Class 2, Special Controls

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 517
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K802342.
AUFRANC-TURNER TYPE ACETABULAR COMPON
K813600 · Intermedics Orthopedics · Jan 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