Cleared Traditional

K890902 - BIOFIX* BIODEGRADABLE FIXATION ROD

K890902 is an FDA 510(k) clearance for BIOFIX* BIODEGRADABLE FIXATION ROD, manufactured by Davis & Geck, Inc.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K890902 · Davis & Geck, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1989
Decision
254d
Days
Class 2
Risk

K890902 is an FDA 510(k) clearance for the BIOFIX* BIODEGRADABLE FIXATION ROD. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Davis & Geck, Inc. (Danbury, US). The FDA issued a Cleared decision on November 3, 1989 after a review of 254 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 Davis & Geck, Inc. devices

FDA 510(k) Submission Details - K890902

510(k) Number K890902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1989
Decision Date November 03, 1989
Days to Decision 254 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
132d slower than avg
Panel avg: 122d · This submission: 254d
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 102
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K890902.
ACUFEX BIOFIX ABSORBABLE FIXATION ROD-MODIFICATION
K922766 · Acufex Microsurgical, Inc. · Jul 1993
K-WIRE
K903264 · Onyx Medical Corp. · Jul 1990
STEINMAN PIN
K903265 · Onyx Medical Corp. · Jul 1990
ACE BEADED K-WIRES ACE OLIVE WIRES
K895079 · Buckman Co., Inc. · Sep 1989
ORTHOMET PIN SYSTEM
K874913 · Orthomet, Inc. · Jan 1988
PDS (POLYDIOXANON) ABSORBABLE PIN
K864912 · Johnson & Johnson Professionals, Inc. · Jul 1987