Cleared Traditional

K080329 - CAP PLUS

K080329 is an FDA 510(k) clearance for CAP PLUS, manufactured by Etex Corp.. The device is a Class 2 Orthopedic device with product code MBP cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K080329 · Etex Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
81d
Days
Class 2
Risk

K080329 is an FDA 510(k) clearance for the CAP PLUS, EQUIVABONE, CAP/DBM. Classified as Filler, Bone Void, Osteoinduction (w/o Human Growth Factor) (product code MBP), Class II - Special Controls.

Submitted by Etex Corp. (Cambridge, US). The FDA issued a Cleared decision on April 28, 2008 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - 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 Etex Corp. devices

FDA 510(k) Submission Details - K080329

510(k) Number K080329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 2008
Decision Date April 28, 2008
Days to Decision 81 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 122d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MBP Device Classification - Class 2, Special Controls

Product Code MBP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
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 - MBP Filler, Bone Void, Osteoinduction (w/o Human Growth Factor)

All 19
Devices cleared under the same product code (MBP) and FDA review panel - the closest regulatory comparables to K080329.
CLEARED UNDER GRAFTON II EDBM
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K080399 · Musculoskeletal Transplant Foundation · Oct 2008
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K080405 · Musculoskeletal Transplant Foundation · Aug 2008
SYGNAL DBM
K073329 · Musculoskeletal Transplant Foundation · Feb 2008
OPTECURE
K063685 · Exactech, Inc. · Jun 2007
DBX DEMINERALIZED BONE MATRIX MIX
K063676 · Musculoskeletal Transplant Foundation · Mar 2007