Cleared Traditional

K931588 - SUTTER PROXIMAL INTERPHALANGEAL JOINT

K931588 is an FDA 510(k) clearance for SUTTER PROXIMAL INTERPHALANGEAL JOINT, manufactured by Sutter Corp.. The device is a Class 2 Orthopedic device with product code KYJ cleared through the Traditional 510(k) pathway after a 344-day FDA review.

K931588 · Sutter Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
344d
Days
Class 2
Risk

K931588 is an FDA 510(k) clearance for the SUTTER PROXIMAL INTERPHALANGEAL JOINT. Classified as Prosthesis, Finger, Constrained, Polymer (product code KYJ), Class II - Special Controls.

Submitted by Sutter Corp. (San Diego, US). The FDA issued a Cleared decision on March 10, 1994 after a review of 344 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3230 - 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 Corp. devices

FDA 510(k) Submission Details - K931588

510(k) Number K931588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1993
Decision Date March 10, 1994
Days to Decision 344 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 122d · This submission: 344d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KYJ Device Classification - Class 2, Special Controls

Product Code KYJ Prosthesis, Finger, Constrained, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3230
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.