Cleared Traditional

K010554 - MENISCUS ARROW SHEATH #CN1000A

Also marketed or referenced as:
SMARTSCREW ACL SHEATH #SSA2000A

K010554 is an FDA 510(k) clearance for MENISCUS ARROW SHEATH #CN1000A, manufactured by Bionx Implants, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K010554 · Bionx Implants, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
88d
Days
Class 2
Risk

K010554 is an FDA 510(k) clearance for the MENISCUS ARROW SHEATH #CN1000A. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Bionx Implants, Inc. (Tampere, FI). The FDA issued a Cleared decision on May 25, 2001 after a review of 88 days - a notably fast clearance 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: 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 Bionx Implants, Inc. devices

FDA 510(k) Submission Details - K010554

510(k) Number K010554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2001
Decision Date May 25, 2001
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 741
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K010554.
PLUS CANCELLOUS BONE SCREWS
K011719 · Plus Orthopedics · Jul 2001
MODIFICATION TO THE BOLD SCREW
K011262 · New Deal, S.A. · Jun 2001
2.0/2.4 CANNULATED SCREW SYSTEM
K010783 · Osteomed Corp. · May 2001
ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM
K010525 · Arthrex, Inc. · May 2001
RIGIDFIX SOFT TISSUE ACL CROSSPIN SYSTEM
K010633 · Mitek Products · May 2001
LACTOSORB 5.0 MM WASHER
K001581 · Biomet, Inc. · Mar 2001