Cleared Traditional

K010884 - TITANIUM COMPRESSION ANCHOR SYSTEM

K010884 is an FDA 510(k) clearance for TITANIUM COMPRESSION ANCHOR SYSTEM, manufactured by Anchor Medical Technologies. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K010884 · Anchor Medical Technologies · Orthopedic device
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Jun 2001
Decision
89d
Days
Class 2
Risk

K010884 is an FDA 510(k) clearance for the TITANIUM COMPRESSION ANCHOR SYSTEM. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Anchor Medical Technologies (Irvine, US). The FDA issued a Cleared decision on June 20, 2001 after a review of 89 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 Anchor Medical Technologies devices

FDA 510(k) Submission Details - K010884

510(k) Number K010884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2001
Decision Date June 20, 2001
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 122d · This submission: 89d
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 905
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K010884.
IN-FAST BONE SCREW SYSTEM
K011910 · American Medical Systems, Inc. · Jul 2001
AUTO-DRIVE LAG SCREW SYSTEM
K010964 · Osteomed Corp. · Jul 2001
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
MENISCUS ARROW SHEATH #CN1000A
K010554 · Bionx Implants, Inc. · May 2001