Cleared Traditional

K944544 - ABSORBABLE BONE SCREW

K944544 is the FDA 510(k) clearance for ABSORBABLE BONE SCREW by Johnson & Johnson Professionals, Inc.. It is a Class 2 Orthopedic device (product code MAI) cleared through the Traditional 510(k) pathway after a 498-day FDA review.

K944544 · Johnson & Johnson Professionals, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jan 1996
Decision
498d
Days
Class 2
Risk

K944544 is an FDA 510(k) clearance for the ABSORBABLE BONE SCREW. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Johnson & Johnson Professionals, Inc. (East Windsor, US). The FDA issued a Cleared decision on January 26, 1996 after a review of 498 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Johnson & Johnson Professionals, Inc. devices

Submission Details

510(k) Number K944544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1994
Decision Date January 26, 1996
Days to Decision 498 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
376d slower than avg
Panel avg: 122d · This submission: 498d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 170
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K944544.
BIOASBSORBABLE MINI-SCREW SUTURE ANCHOR
K960555 · Instrument Makar, Inc. · Jul 1996
BIO-ANCHOR
K955486 · Linvatec Corp. · Feb 1996
PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM
K952687 · Ethicon, Inc. · Feb 1996
RESORBABLE SOFT TISSUE ATTACHMENT DEVICE
K950275 · Zimmer, Inc. · Nov 1995
BIOABSORBABLE INTERFERENCE SCREW
K943249 · Instrument Makar, Inc. · Jul 1995
ACUFEX ENDOBUTTON SYSTEM
K933948 · Acufex Microsurgical, Inc. · Jul 1994