Cleared Traditional

K011985 - SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT

K011985 is an FDA 510(k) clearance for SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT AN..., manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code MAI cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K011985 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2001
Decision
129d
Days
Class 2
Risk

K011985 is an FDA 510(k) clearance for the SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT. Classified as Fastener, Fixation, Biodegradable, Soft Tissue (product code MAI), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on November 2, 2001 after a review of 129 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.

FDA 510(k) Submission Details - K011985

510(k) Number K011985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2001
Decision Date November 02, 2001
Days to Decision 129 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
7d slower than avg
Panel avg: 122d · This submission: 129d
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 220
Devices cleared under the same product code (MAI) and FDA review panel - the closest regulatory comparables to K011985.
TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212
K032197 · Smith & Nephew, Inc. · Aug 2003
2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445
K031981 · Linvatec Biomaterials, Ltd. · Jul 2003
CUFFLOK ANCHOR
K031519 · Mitek Worldwide · Jun 2003
MULTITAK SPLINTER 3.0 MM RESORBABLE ANCHOR
K012465 · Bonutti Research, Inc. · Oct 2001
BIOCUFF,C, MODELS 236018, 236028, 236036
K013057 · Bionx Implants, Inc. · Oct 2001
CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116
K012334 · Bionx Implants, Inc. · Sep 2001
K011985 · SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT
Download PDF FDA Summary Smith & Nephew, Inc.