Cleared Traditional

ORTHOPEDIC PACKS (K951231) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K951231 · Sterile Concepts, Inc. · General & Plastic Surgery device
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Dec 1995
Decision
256d
Days
Class 2
Risk

K951231 is an FDA 510(k) clearance for the ORTHOPEDIC PACKS. Classified as Suture, Absorbable, Synthetic (product code GAN), Class II - Special Controls.

Submitted by Sterile Concepts, Inc. (Richmond, US). The FDA issued a Cleared decision on December 1, 1995 after a review of 256 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4830 - the FDA general and plastic surgery device 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Sterile Concepts, Inc. devices

Submission Details

510(k) Number K951231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1995
Decision Date December 01, 1995
Days to Decision 256 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 115d · This submission: 256d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GAN Suture, Absorbable, Synthetic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4830
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAN Suture, Absorbable, Synthetic

Devices cleared under the same product code (GAN) and FDA review panel - the closest regulatory comparables to K951231.
MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED
K964072 · Ethicon, Inc. · Dec 1996
MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)
K960653 · Ethicon, Inc. · Mar 1996
ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED
K920978 · Ethicon, Inc. · Feb 1994
POLYSORB SYNTHETIC ABSORBABLE SUTURE
K895579 · United States Surgical, A Division of Tyco Healthc · Jul 1990