Cleared Traditional

K082231 - ASCENSION SILICONE PIP

K082231 is an FDA 510(k) clearance for ASCENSION SILICONE PIP, manufactured by Ascension Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code KYJ cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K082231 · Ascension Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
158d
Days
Class 2
Risk

K082231 is an FDA 510(k) clearance for the ASCENSION SILICONE PIP. Classified as Prosthesis, Finger, Constrained, Polymer (product code KYJ), Class II - Special Controls.

Submitted by Ascension Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on January 12, 2009 after a review of 158 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3230 - 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 Ascension Orthopedics, Inc. devices

FDA 510(k) Submission Details - K082231

510(k) Number K082231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2008
Decision Date January 12, 2009
Days to Decision 158 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
36d slower than avg
Panel avg: 122d · This submission: 158d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KYJ Device Classification - Class 2, Special Controls

Product Code KYJ Prosthesis, Finger, Constrained, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3230
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 - KYJ Prosthesis, Finger, Constrained, Polymer

All 8
Devices cleared under the same product code (KYJ) and FDA review panel - the closest regulatory comparables to K082231.
BRM Digitalis Spacer
K220142 · Brm Extremities Srl · Apr 2023
KeriFlex® MCP and PIP Finger Joint Prostheses
K211385 · Keri Medical SA · Jul 2022
MODIFICATION TO DEPUY NEUFLEX PIP FINGER
K083107 · DePuy Orthopaedics, Inc. · Feb 2009
ASCENSION SILLICONE MCP
K022892 · Ascension Orthopedics, Inc. · Nov 2002
DEPUY NEUFLEX PIP FINGER
K001922 · Depuy, Inc. · Aug 2000
DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS
K970544 · Depuy, Inc. · Sep 1997