Cleared Special

K010983 - PLLA PIN

K010983 is an FDA 510(k) clearance for PLLA PIN, manufactured by Bionx Implants, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Special 510(k) pathway after a 72-day FDA review.

K010983 · Bionx Implants, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
72d
Days
Class 2
Risk

K010983 is an FDA 510(k) clearance for the PLLA PIN. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Bionx Implants, Inc. (Tampere, FI). The FDA issued a Cleared decision on June 13, 2001 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K010983

510(k) Number K010983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2001
Decision Date June 13, 2001
Days to Decision 72 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 122d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

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 197
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K010983.
OPUS MAGNUM ANCHOR & INSERTER
K012125 · Opus Medical, Inc. · Sep 2001
FLEX-NAILS
K012161 · Fixano SA · Aug 2001
RESORBABLE BONE PINS
K011522 · Biomet, Inc. · Jul 2001
MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR
K010479 · Bonutti Research, Inc. · May 2001
MODIFICATION TO SYNTHES (USA) POLYPIN
K003527 · Synthes (Usa) · Apr 2001
PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260
K003659 · Bionx Implants, Inc. · Feb 2001
K010983 · PLLA PIN
Download PDF FDA Summary Bionx Implants, Inc.