Cleared Traditional

K161279 - Life Spine Metatarsal Hemi Implant

K161279 is an FDA 510(k) clearance for Life Spine Metatarsal Hemi Implant, manufactured by Life Spine, Inc.. The device is a Class 2 Orthopedic device with product code KWD cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K161279 · Life Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
271d
Days
Class 2
Risk

K161279 is an FDA 510(k) clearance for the Life Spine Metatarsal Hemi Implant. Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Life Spine, Inc. (Huntley, US). The FDA issued a Cleared decision on February 1, 2017 after a review of 271 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3730 - 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 Life Spine, Inc. devices

FDA 510(k) Submission Details - K161279

510(k) Number K161279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2016
Decision Date February 01, 2017
Days to Decision 271 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
149d slower than avg
Panel avg: 122d · This submission: 271d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWD Device Classification - Class 2, Special Controls

Product Code KWD Prosthesis, Toe, Hemi-, Phalangeal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3730
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 - KWD Prosthesis, Toe, Hemi-, Phalangeal

All 35
Devices cleared under the same product code (KWD) and FDA review panel - the closest regulatory comparables to K161279.
Accu-Joint Hemi Implant
K200951 · Accufix Surgical, Inc. · Dec 2020
BOSS Toe Fixation System
K190261 · Arthrosurface, Inc. · Aug 2019
Cannulated Hemi Implant
K190543 · Vilex IN Tennessee, Inc. · May 2019
HemiCAP MTP Resurfacing Hemi-Arthroplasty System
K152454 · Arthrosurface, Inc. · Apr 2016
HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT
K131377 · Arthrosurface, Inc. · Nov 2013
LESSER METATARSAL HEAD IMPLANT SYSTEM
K131187 · Solana Surgical, LLC · Oct 2013