Cleared Traditional

K061389 - ALLTHREAD LACTOSORB SUTURE ANCHOR

K061389 is an FDA 510(k) clearance for ALLTHREAD LACTOSORB SUTURE ANCHOR, manufactured by Arthrotek, Inc.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K061389 · Arthrotek, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
62d
Days
Class 2
Risk

K061389 is an FDA 510(k) clearance for the ALLTHREAD LACTOSORB SUTURE ANCHOR. Classified as Staple, Fixation, Bone (product code JDR), Class II - Special Controls.

Submitted by Arthrotek, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 19, 2006 after a review of 62 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arthrotek, Inc. devices

FDA 510(k) Submission Details - K061389

510(k) Number K061389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2006
Decision Date July 19, 2006
Days to Decision 62 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
60d faster than avg
Panel avg: 122d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, Fixation, Bone
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 - JDR Staple, Fixation, Bone

All 195
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K061389.
BIOPRO MEMORY STAPLE
K061798 · Biopro, Inc. · Aug 2006
2.8 & 3.5MM LACTOSCREW SUTURE ANCHORS
K061801 · Arthrotek, Inc. · Aug 2006
HITCH LACTOSORB SUTURE ANCHOR
K061657 · Arthrotek, Inc. · Jul 2006
AXYALOOP NONABSORBABLE BONE ANCHOR
K060970 · Axya Medical, Inc. · Jul 2006
LARGE UNI-CLIP STAPLE
K061594 · New Deal, S.A. · Jul 2006
MEMORY STAPLE
K060746 · DePuy Orthopaedics, Inc. · May 2006