Cleared Traditional

K955486 - BIO-ANCHOR

K955486 is an FDA 510(k) clearance for BIO-ANCHOR, manufactured by Linvatec Corp.. The device is a Class 2 Orthopedic device with product code MAI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K955486 · Linvatec Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
90d
Days
Class 2
Risk

K955486 is an FDA 510(k) clearance for the BIO-ANCHOR. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on February 29, 1996 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Linvatec Corp. devices

FDA 510(k) Submission Details - K955486

510(k) Number K955486 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 01, 1995
Decision Date February 29, 1996
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAI Device Classification - Class 2, Special Controls

Product Code MAI Fastener, Fixation, Biodegradable, Soft Tissue
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - MAI Fastener, Fixation, Biodegradable, Soft Tissue

All 209
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K955486.
RESORBABLE SOFT TISSUE ATTACHMENT DEVICE
K961789 · Zimmer, Inc. · Aug 1996
BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR
K960555 · Instrument Makar, Inc. · Jul 1996
BIOFIX BIODEGRADABLE MENISCUS ARROW SYSTEM
K955768 · Bioscience, Inc. · Mar 1996
PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM
K952687 · Ethicon, Inc. · Feb 1996
BIOFIX BIODEGRADABLE SELF-REINFORCED POLY-L-LACTIDE (SR-PLLA) MINI-TACK
K955003 · Bioscience, Inc. · Jan 1996
ABSORBABLE BONE SCREW
K944544 · Johnson & Johnson Professionals, Inc. · Jan 1996