Who is the manufacturer of PROXIMAL FEMORAL NAIL (PFN) SYSTEM?

Synthes (Usa) filed the 510(k) submission for PROXIMAL FEMORAL NAIL (PFN) SYSTEM (K970097).

What is the FDA product code for PROXIMAL FEMORAL NAIL (PFN) SYSTEM?

JDW. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for PROXIMAL FEMORAL NAIL (PFN) SYSTEM?

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

Who can help prepare an FDA 510(k) submission like PROXIMAL FEMORAL NAIL (PFN) SYSTEM?

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.

PROXIMAL FEMORAL NAIL (PFN) SYSTEM

K970097 · Synthes (Usa) · JDW · Mar 13, 1997 · Orthopedic

Device Facts

Record ID	K970097
Device Name	PROXIMAL FEMORAL NAIL (PFN) SYSTEM
Applicant	Synthes (Usa)
Product Code	JDW · Orthopedic
Decision Date	Mar 13, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Synthes PFN System is intended to treat stable and unstable proximal femoral fractures including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures.

Device Story

Intramedullary nail system for proximal femoral fracture fixation; utilizes weightbearing dynamic femoral neck screw and anti-rotational parallel hip pin; distal interlocking via static or dynamic locking bolts. Used in surgical settings by orthopedic surgeons. Provides mechanical stabilization of fractures to facilitate healing. Components include titanium alloy/stainless steel nails, hip pins, neck screws, locking bolts, and end caps.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Intramedullary nail system; materials: titanium alloy and stainless steel; proximal diameter 17 mm, length 240 mm; neck/shaft angle 125°-140°; components: 6.5 mm hip pin, 11 mm femoral neck screw, 4.9 mm locking bolts, 17 mm end caps.

Indications for Use

Indicated for patients with stable and unstable proximal femoral fractures, including pertrochanteric, intertrochanteric, and high subtrochanteric fractures, and combinations thereof.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

Howmedica’s Gamma Locking Nail (GLN)

Related Devices

K973240 — SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION · Synthes (Usa) · Nov 20, 1997
K233134 — I.T.S. INS Proximal Femur Nail · I.T.S. GmbH · Feb 12, 2024
K042325 — TROCHANTERIC NAIL SYSTEM · DePuy Orthopaedics, Inc. · Sep 8, 2004
K050226 — ASIAN INTRAMEDULLARY HIP SCREW NAILS · Smith & Nephew, Inc. · Feb 11, 2005
K092748 — SURESHOT TAN NAILS AND ACCESSORIES · Smith & Nephew, Inc. · Apr 26, 2010

Submission Summary (Full Text)

{0} SYNTHES K970097 Attachment IX: Summary of Safety and Effectiveness Information [510(k) Summary] Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700 Contact: Sheri Musgnung January 1997 MAR 13 1997 Synthes Proximal Femoral Nail (PFN) is compared to Howmedica’s Gamma Locking Nail (GLN). The Synthes PFN System is intended to treat stable and unstable proximal femoral fractures including pertrochanteric fractures, intertrochanteric fractures, high subtrochanteric fractures, and combinations of these fractures. Howmedica’s GLN is intended to treat stable and unstable proximal femoral fractures including pertrochanteric fractures, intertrochanteric fractures, and high subtrochanteric fractures (without distal extensions). Synthes PFN System is an intramedullary nail which utilizes a weightbearing dynamic femoral neck screw and an anti-rotational parallel hip pin. Distal interlocking is performed with an aiming arm and can be either static or dynamic. The following components makeup the PFN system: proximal femoral nails, hip pins, femoral neck screws, 4.9 mm locking bolts, and 17 mm end caps. The PFN has a 17 mm proximal diameter, and is 240 mm in length. The PFN features an angle between femoral neck / shaft ranging from 125° - 140°. It has two proximal holes: one is 6.5 mm in diameter and the other is 11 mm in diameter. Two distal holes accept the 4.9 mm locking bolts. The hip pin, femoral neck screws, and 4.9 mm locking bolts are used to lock the PFN into place. The hip pin is 6.5 mm in diameter and is available in lengths ranging from 75 mm to 120 mm. The femoral neck screw is 11 mm in diameter and is available in lengths ranging from 80 mm to 120 mm. The 4.9 mm locking bolts have a 4.9 mm diameter and are available in lengths ranging from 26 mm to 100 mm. The proximal end of the PFN accepts a 17 mm end cap. The end cap is 17 mm in diameter and is available in 0 to 15 mm extensions. Synthes PFN System is manufactured from a titanium alloy and stainless steel. Based on the mechanical test results, the PFN is at least equivalent to the GLN.