PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE

K961267 · Pioneer Surgical Technology · JDQ · Jun 27, 1996 · Orthopedic

Device Facts

• Record ID: K961267
• Device Name: PIONEER SYSTEM GTR(GREATER TROCHANTEER REATTACHMENT) DEVICE
• Applicant: Pioneer Surgical Technology
• Product Code: JDQ · Orthopedic
• Decision Date: Jun 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GTR Device is used for the reattachment of the greater trochanter following osteotomy in total hip arthroplasty. Additionally, the device is used to reattach the greater trochanter following fracture of the greater trochanter.

Device Story

System consists of low-profile ovaloid stabilizer and multifilament cables; used for greater trochanter reattachment post-osteotomy or fracture. Stabilizer features proximal fingers for positioning and distal force application; extended version includes distal plate stem. Cables pass around/through femur, anchor to stabilizer, and are tensioned via instrument; secured by screw-driven crimping sleeve. Used by orthopedic surgeons in clinical/OR settings. Provides mechanical fixation to stabilize bone fragments; promotes healing/alignment post-surgery.

Clinical Evidence

Bench testing only. Static and fatigue loading tests compared Pioneer GTR, Dall-Miles system, and stainless steel wire. Pioneer GTR demonstrated static and fatigue performance equal to or greater than the Dall-Miles predicate and superior to stainless steel wire systems.

Technological Characteristics

Materials: Titanium stabilizer, cobalt chrome cables. Design: Ovaloid stabilizer with proximal hooks; extended version includes distal plate stem. Fixation: Multifilament cables secured via screw-driven crimping sleeve. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring reattachment of the greater trochanter following osteotomy during total hip arthroplasty or following fracture of the greater trochanter.

Regulatory Classification

Identification

A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

Predicate Devices

• Dall-Miles Trochanter Cable Grip (Howmedica)

Submission Summary (Full Text)

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JAN 27 1996
K96/267

# PIONEER LABORATORIES
## 510(K) NOTIFICATION SUMMARY
### for
### GTR (Greater Trochanteric Reattachment) DEVICE

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## ADMINISTRATIVE INFORMATION

**Manufacturer Identification and Sponsor:**

Pioneer Laboratories
375 River Park Circle
Marquette, MI 49855
Phone [phone]
FAX [phone]

**Official Contact:**

Steve Severson
Vice President, Regulatory Affairs/Quality Assurance

**Date Prepared:** 3/26/96

## DEVICE IDENTIFICATION

**Proprietary Name:**

Pioneer System GTR (Greater Trochanter Reattachment) Device

**Classification Name:**

Cerclage, Bone Fixation CFR 888.3010

**Device on which substantial equivalence is claimed:**

Dall-Miles Trochanter Cable Grip manufactured by Howmedica

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GTR 510(k) Summary
Establishment Registration Number: 1833824
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# DEVICE DESCRIPTION

The Pioneer Greater trochanteric Reattachment Device (GTR) is a low profile, ovaloid stabilizer combined with multifilament cables. The cables are affixed to the ovaloid stabilizer and serve to attach the device to the trochanter providing fixation. Instruments that tension and lock the cable are provided with the GTR system. The GTR is offered in two (2) styles.

The GTR stabilizer is designed with proximal fingers which hook over the top of the proximal osteotomized trochanter and serve to position the device during fixation and apply a distal force after fixation. The extended version incorporates a distal plate stem.

The cables are affixed to the GTR unit are passed around or through the femur and back into the GTR Device. The ovaloid GTR unit is placed on the osteotomized trochanter which is then positioned on the femur. Proper tensioning is applied to the cables with a tensioning instrument. The cables are then locked in place by tightening a screw which crimps a sleeve and cable.

# INTENDED USE

The GTR Device is used for the reattachment of the greater trochanter following osteotomy in total hip arthroplasty. Additionally, the device is used to reattach the greater trochanter following fracture of the greater trochanter.

# SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO PREDICATE DEVICE

Both devices utilize cable which holds the device and anchors the trochanter. The cables are crimped into place. The Dall-Miles device utilizes a crimping tool whereas the Pioneer device uses a screw.

The Dall-Miles device is H-shaped whereas the Pioneer device is oval. Both use proximal hooks for the top of the osteotomized trochanter. Both offer cobalt chrome cable. The Pioneer device is made of titanium--the Dall-Miles cobalt chrome.

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GTR 510(k) Summary
Establishment Registration Number: 1833824
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# PERFORMANCE DATA

The Pioneer Laboratories device was predicated on the use of stainless steel wire and the Dall-Miles Cable Grip System. All three systems were tested in static and fatigue loadings. Both the Pioneer and Dall-Miles Greater Trochanteric Reattachment Devices exceeded the static and fatigue values obtained by wire systems. Additionally, values obtained indicate the Pioneer GTR equaled or was greater than Dall-Miles.

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