Cleared Traditional

K010479 - MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR

K010479 is an FDA 510(k) clearance for MULTITAK CONICAL TIP BONE SOFT TISSUE S..., manufactured by Bonutti Research, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K010479 · Bonutti Research, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
77d
Days
Class 2
Risk

K010479 is an FDA 510(k) clearance for the MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Bonutti Research, Inc. (Effingham, US). The FDA issued a Cleared decision on May 8, 2001 after a review of 77 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K010479

510(k) Number K010479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2001
Decision Date May 08, 2001
Days to Decision 77 days
Submission Type Traditional
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
45d faster than avg
Panel avg: 122d · This submission: 77d
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 197
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K010479.
FLEX-NAILS
K012161 · Fixano SA · Aug 2001
RESORBABLE BONE PINS
K011522 · Biomet, Inc. · Jul 2001
PLLA PIN
K010983 · Bionx Implants, Inc. · Jun 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
PINS AND WIRES
K002125 · Implant Resource, Inc. · Oct 2000
K010479 · MULTITAK CONICAL TIP BONE SOFT TISSUE SUTURE ANCHOR
Download PDF FDA Summary Bonutti Research, Inc.