Cleared Special

K110787 - TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)

K110787 is an FDA 510(k) clearance for TRIPORE TDD (HA), manufactured by Orthogem Limited. The device is a Class 2 Orthopedic device with product code MQV cleared through the Special 510(k) pathway after a 31-day FDA review.

K110787 · Orthogem Limited · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
31d
Days
Class 2
Risk

K110787 is an FDA 510(k) clearance for the TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15). Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Orthogem Limited (Nottingham, GB). The FDA issued a Cleared decision on April 21, 2011 after a review of 31 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K110787

510(k) Number K110787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2011
Decision Date April 21, 2011
Days to Decision 31 days
Submission Type Special
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
91d faster than avg
Panel avg: 122d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

MQV Device Classification - Class 2, Special Controls

Product Code MQV Filler, Bone Void, Calcium Compound
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 - MQV Filler, Bone Void, Calcium Compound

All 492
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K110787.
NOVABONE MACROPOR-SI+ - BIOACTIVE BONE GRAFT
K110925 · Novabone Products, LLC · Jul 2011
ORIGEN DBM WITH BIOACTIVE GLASS, NANOFUSE DBM
K110976 · Nanotherapeutics, Inc. · May 2011
FORTROSS BONE VOID FILLER
K110561 · Pioneer Surgical Technology · Apr 2011
NOVABONE PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT
K110368 · Novabone Products, LLC · Apr 2011
DBX DEMINERALIZED BONE MATRIX PUTTY
K103784 · Musculoskeletal Transplant Foundation · Apr 2011
DBX DEMINERALIZED BONE MATRIX PUTTY
K103795 · Musculoskeletal Transplant Foundation · Apr 2011
K110787 · TRIPORE TDD (HA), TRIPORE TDD (BP90), TRIPORE TDD (BP15)
Download PDF FDA Summary Orthogem Limited