Who is the manufacturer of DEPUY ACE AIM TITANIUM TIBIAL NAIL?

Depuy Ace Medical Co. filed the 510(k) submission for DEPUY ACE AIM TITANIUM TIBIAL NAIL (K970202).

What is the FDA product code for DEPUY ACE AIM TITANIUM TIBIAL NAIL?

HSB. It is classified under 21 CFR 888.3020 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for DEPUY ACE AIM TITANIUM TIBIAL NAIL?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like DEPUY ACE AIM TITANIUM TIBIAL NAIL?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DEPUY ACE AIM TITANIUM TIBIAL NAIL

Q: What are the predicate devices for DEPUY ACE AIM TITANIUM TIBIAL NAIL?

DePuy ACE AIM® Titanium Tibial Nail.

K970202 · Depuy Ace Medical Co. · HSB · Mar 21, 1997 · Orthopedic

Device Facts

Record ID	K970202
Device Name	DEPUY ACE AIM TITANIUM TIBIAL NAIL
Applicant	Depuy Ace Medical Co.
Product Code	HSB · Orthopedic
Decision Date	Mar 21, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3020
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The DePuy ACE AIM® Titanium Tibial Nail is indicated for internal fixation of tibial fractures including transverse fractures, oblique and spiral fractures, comminuted fractures, fractures with bone loss, bone transport, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions metaphyseal fractures and epiphyseal fractures.

Device Story

Intramedullary fixation rod for tibial fracture stabilization; inserted into tibial canal to provide structural support during bone healing. Device features distal bends (2° for 10-13mm diameters; 5° for 8-9mm diameters) to facilitate insertion and prevent posterior cortex perforation. Proximal end includes cross-locking screw holes for cortical bone screws. 8-9mm nails are solid; 10-13mm nails are cannulated. Used by orthopedic surgeons in clinical/OR settings. Provides mechanical stability to bone fragments, promoting union and patient mobility.

Clinical Evidence

Bench testing and cadaveric studies conducted. Cadaveric testing evaluated insertion and extraction forces relative to distal bend angles to optimize surgical performance and minimize cortical perforation risk. No human clinical trial data provided.

Technological Characteristics

Material: Titanium 6Al-4V ELI (ASTM F-136). Diameters: 8.0mm-13.0mm. Lengths: 25.5cm-43.5cm. Configuration: Solid (8-9mm) or cannulated (10-13mm). Distal bend: 2° (large nails) or 5° (small nails). Fixation: Cross-locking screw holes for cortical bone screws.

Indications for Use

Indicated for patients requiring internal fixation of tibial fractures, including transverse, oblique, spiral, comminuted, open, pathologic, metaphyseal, and epiphyseal fractures; also indicated for bone transport, corrective osteotomies, pseudoarthrosis, nonunions, and malunions of the tibial shaft.

Regulatory Classification

Identification

An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.

Predicate Devices

DePuy ACE AIM® Titanium Tibial Nail

Related Devices

K972183 — DEPUY ACE A.I.M. TITANIUM TIBIAL NAIL · Ace Medical Co. · Aug 26, 1997
K032097 — DEPUY ACE VERSANAIL TIBIAL NAIL · DePuy Orthopaedics, Inc. · Aug 8, 2003
K962047 — TITANIUM CANNULATED TIBIAL NAIL (TI CTN) · Synthes (Usa) · Jul 24, 1996
K961027 — ORTHOFIX TIBIAL NAILING SYSTEM · Orthofix, Inc. · May 8, 1996
K955761 — TIBIA ORTHONAIL · Orthologic Corp. · Mar 13, 1996

Submission Summary (Full Text)

{0} K970202 510(k) SUMMARY MAR 21 1997 ## NAME OF FIRM: DePuy ACE Medical Company 2260 East El Segundo Blvd. El Segundo, CA 90245 ## 510(k) CONTACT PERSON Paul Doner Director, Regulatory and Clinical Affairs DePuy ACE Medical Company ## TRADE NAME DePuy ACE AIM® Titanium Tibial Nail ## COMMON NAME Intramedullary Bone Fixation Rod ## CLASSIFICATION 888.3020 Intramedullary Fixation Rod ## DEVICE PRODUCT CODE 87 HSB - class 2 ## SUBSTANTIALLY EQUIVALENT DEVICE DePuy ACE AIM® Titanium Tibial Nail ## INTENDED USE: The DePuy ACE AIM® Titanium Tibial Nail is indicated for internal fixation of tibial fractures including transverse fractures, oblique and spiral fractures, comminuted fractures, fractures with bone loss, bone transport, open fractures, corrective osteotomies, pathologic fractures, pseudoarthrosis of the tibial shaft, nonunions, malunions metaphyseal fractures and epiphyseal fractures. ## DEVICE DESCRIPTION AND SUBSTANTIAL EQUIVALENCE RATIONALES: The DePuy ACE AIM® Titanium Tibial Nail is an intramedullary fixation rod for the fixation of tibial fractures. The nail has a distal bend of 2° for the nails of 10mm, 11mm, 12mm and 13mm diameters. The distal bend in the nails of 8mm and 9mm diameters is 5°. The DePuy ACE AIM® Titanium Tibial Nail has diameters from 8.0mm to 13.0mm and lengths from 25.5 cm to 43.5cm. The proximal end of the 10mm, 11mm, 12mm and 13mm nails is 13mm in diameter while the proximal end of the 8mm and 9mm nails is 11mm in diameter. The proximal end of the nail contains two 6mm cross locking screw holes which accept 5.5mm solid cortical bone screws. The distal end of the nail contains two 5.0mm holes which accept 4.5mm solid cortical bone screws. The 8mm and 9mm nails are solid while the 10mm to 13mm nails are cannulated. The DePuy ACE AIM® Titanium Tibial Nail is manufactured from Titanium 6Al-4V ELI (ASTM standard F-136) Comparative testing between the versions of the tibial nails was conducted on cadavers which showed that the insertion and extraction forces are decreased by reducing the distal bend for a 13mm nail. Under clinical usage, it is believed that a distal bend is necessary during insertion to reduce the likelihood of fracturing or perforating the posterior cortex. Therefore, the distal bend of the large tibial nails will be reduced to 2°. The 8mm and 9mm nails are used in unreamed applications. Due to their small diameter, difficulty during insertion and extraction has not been encountered. Therefore, the small nails will keep the a 5° distal bend. Based on this information, DePuy Ace believes that the modified DePuy ACE AIM® Titanium Tibial Nails are substantially equivalent to the DePuy ACE AIM® Titanium Tibial Nail previously cleared for tibial fractures.