Cleared Traditional

K133662 - SMITH & NEPHEW CANNULATED CAPTURED SCREW

K133662 is an FDA 510(k) clearance for SMITH & NEPHEW CANNULATED CAPTURED SCREW, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K133662 · Smith & Nephew, Inc. · Orthopedic device
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May 2014
Decision
167d
Days
Class 2
Risk

K133662 is an FDA 510(k) clearance for the SMITH & NEPHEW CANNULATED CAPTURED SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on May 15, 2014 after a review of 167 days - an extended review 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: 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.

View all Smith & Nephew, Inc. devices

FDA 510(k) Submission Details - K133662

510(k) Number K133662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2013
Decision Date May 15, 2014
Days to Decision 167 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
45d slower than avg
Panel avg: 122d · This submission: 167d
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 929
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K133662.
DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT
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NORMED VARIO SUBTALAR SCREW
K140962 · Normed Nedizin Technik GmbH · Jul 2014
BIOMET CANNULATED SCREW SYSTEM
K140891 · Biomet, Inc. · Jun 2014
SALVATION BEAMS AND BOLTS SYSTEM
K140741 · Wrightmedicaltechnologyinc · May 2014
CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW
K140952 · Wrightmedicaltechnologyinc · May 2014
SALVATION OSTEOPENIC SCREW
K140408 · Wrightmedicaltechnologyinc · May 2014