Cleared Traditional

K864912 - PDS (POLYDIOXANON) ABSORBABLE PIN

K864912 is an FDA 510(k) clearance for PDS (POLYDIOXANON) ABSORBABLE PIN, manufactured by Johnson & Johnson Professionals, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K864912 · Johnson & Johnson Professionals, Inc. · Orthopedic device
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Jul 1987
Decision
206d
Days
Class 2
Risk

K864912 is an FDA 510(k) clearance for the PDS (POLYDIOXANON) ABSORBABLE PIN. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on July 9, 1987 after a review of 206 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Johnson & Johnson Professionals, Inc. devices

FDA 510(k) Submission Details - K864912

510(k) Number K864912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1986
Decision Date July 09, 1987
Days to Decision 206 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
84d slower than avg
Panel avg: 122d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - HTY Pin, Fixation, Smooth

All 174
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K864912.
ACE BEADED K-WIRES ACE OLIVE WIRES
K895079 · Buckman Co., Inc. · Sep 1989
ORTHOMET PIN SYSTEM
K874913 · Orthomet, Inc. · Jan 1988
PIN, HIP, KNOWLES
K872842 · Military Engineering, Inc. · Aug 1987
STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS
K863734 · Micro-Aire Surgical Instruments, Inc. · Oct 1986
CANNULATED LAG SCREWS
K863119 · Downs Surgical , Ltd. · Sep 1986
ACE UNILATERAL FIXATOR
K860590 · Buckman Co., Inc. · Mar 1986