Cleared Special

K011136 - APEX FIXATION PINS

K011136 is the FDA 510(k) clearance for APEX FIXATION PINS by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code JDW) cleared through the Special 510(k) pathway after a 21-day FDA review.

K011136 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
21d
Days
Class 2
Risk

K011136 is an FDA 510(k) clearance for the APEX FIXATION PINS. Classified as Pin, Fixation, Threaded (product code JDW), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on May 4, 2001 after a review of 21 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.

View all Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K011136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2001
Decision Date May 04, 2001
Days to Decision 21 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
101d faster than avg
Panel avg: 122d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JDW Pin, Fixation, Threaded
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 - JDW Pin, Fixation, Threaded

All 52
Devices cleared under the same product code (JDW) and FDA review panel - the closest regulatory comparables to K011136.
STRYKER CROSS-PINNED INTERFERENCE SCREW SYSTEM
K012270 · Stryker Endoscopy · Sep 2001
STRYKER TITANIUM CROSS-SCREW SYSTEM, MODEL 234-500-1XX
K011319 · Stryker Endoscopy · Jul 2001
RESORBABLE HAMMERTOE PIN
K011137 · Biomet, Inc. · Jun 2001
4.0/2.5 MM SELF-DRILLING SCHANZ SCREW
K002605 · Synthes (Usa) · Nov 2000
BIOMET LATERAL TROCH PLATE
K003294 · Biomet, Inc. · Nov 2000
MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT
K003131 · Biomet, Inc. · Nov 2000