COMPRESSION CERCLAGE GUNDOLF CCG-GF

K973098 · Plus Orthopedics · JDQ · Oct 27, 1997 · Orthopedic

Device Facts

• Record ID: K973098
• Device Name: COMPRESSION CERCLAGE GUNDOLF CCG-GF
• Applicant: Plus Orthopedics
• Product Code: JDQ · Orthopedic
• Decision Date: Oct 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Compression Cerclage Gundolf CCG is suitable for particular forms of osteosynthesis, particularly for cerclage of the greater trochanter and femur associated with revision hip arthroplasties. In contrast to cerclage wires, the CCG compression band allows a functional compression to be achieved. An assumption is made that an indication for implant revision already exists. - Reattachment of the greater trochanter. - Bone support in case of a damaged proximal femur (e.g. by bone cement, loosened stem, or polyethylene wear particles), with a possible cancellous bone graft in the proximal femur area. - Cerclage of bone fissures. - Fracture protection during rasping of a new prosthetic canal and prior to implantation of a new stem. - Closing of a cortical fenestration. - Fractures in the area of the femoral stem. - To improve bone-cement interface. In general, CCG and CCG-GF have the same function. In the case of conical shape of the bone, primarily superior to the lesser trochanter, the CCG-GF is indicated rather than the CCG.

Device Story

The Compression Cerclage Gundolf CCG-GF is a titanium bone fixation band used in orthopedic surgery. It consists of a 270 mm long, 7.7 mm wide, 0.5 mm thick band with an integrated fastener and two 2.9 mm conical spikes. The device is applied around the bone in a belt-like manner; a manual tightening instrument imparts compression to the bone to stabilize fractures or support bone grafts. The excess band is removed with a wire cutter. The spikes prevent slippage and enhance stability during osteointegration. Used by orthopedic surgeons in clinical settings during revision hip arthroplasties or fracture management. The device provides functional compression, improving bone-cement interfaces and protecting bone during prosthetic implantation, thereby facilitating healing and structural support.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Commercially pure wrought titanium (ISO 5832-2, ASTM F-67). Dimensions: 270 mm x 7.7 mm x 0.5 mm. Features: Integrated fastener, two 2.9 mm conical spikes. Principle: Mechanical compression band for bone fixation. Operation: Manual tightening instrument. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring osteosynthesis, specifically cerclage of the greater trochanter and femur during revision hip arthroplasty. Applicable for reattachment of the greater trochanter, bone support for damaged proximal femur, cerclage of bone fissures, fracture protection during prosthetic canal rasping, closing cortical fenestrations, femoral stem area fractures, and improving bone-cement interface. CCG-GF specifically indicated for conical bone shapes superior to the lesser 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

• CCG Cerclage System (K932024)

Submission Summary (Full Text)

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K973098
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OCT 2 7 1997

## 510(k) Summary of Safety and Effectiveness Information

(as required by 807.92c), prepared by Hartmut Loch, President of FIFH. Consulting for PLUS Orthopedics in San Diego, California October 22, 1997

Compression Cerclage Gundolf CCG-GF Trade name:

Bone Cerclage Common name:

Bone Fixation Cerclage Classification name:

The Compression Cerclage Gundolf CCG-GF is manufactured from Description: commercially pure wrought titanium according to ISO 5832-2 and ASTM F-67. It is 270 mm long, 7.7 mm wide and 0.5 mm thick. It has a fastener at the end that allows the band to encircle the bone and attach itself in a belt-like manner. By using a special manual, tightening instrument the band can impart compression to the bone The remaining end of the band is cut off using a wire cutter. It has 2 conical shaped 2.9 mm spikes, which are intended to prevent the cerclage band from slipping and give it more stability during the osteointegration period.

The Compression Cerclage Gundolf CCG is suitable for particular Indications: forms of asteosynthesis, particularly for cerclage of the greater trochanter and femur associated with revision hip arthroplasties. In contrast to cerclage wires, the CCG compression band allows a functional compression to be achieved. An assumption is made that an indication for implant revision already exists.

- Reattachment of the greater trochanter. .
- . Bone support in case of a damaged proximal femur (e.g. by bone cement, loosened stem, or polyethylene wear particles), with a possible cancellous bone graft in the proximal femur area.
- t Cerclage of bone fissures.
- 트 Fracture protection during rasping of a new prosthetic canal and prior to implantation of a new stem.
- 트 Closing of a cortical fenestration.
- 트 Fractures in the area of the femoral stem.
- 용 To improve bone-cement interface.

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973098
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510(k) Summary of Safety and Effectiveness Information Compression Cerclage Gundolf CCG-GF (continued)

In general. CCG and CCG-GF have the same function. In the case of conical shape of the bone, primarily superior to the lesser trochanter, the CCG-GF is indicated rather than the CCG."

Comparable Features to Predicate Device: The Compression Cerclage Gundolf CCG-GF is identical in design, material, strength, indications and contra-indications to the CC G Cerclage System, which is being sold by Encore Orthopedics, Inc. in Austin, T × (K .- 932024). In fact, the same company manufactures both cerclage systems: FLUS Endoprothetik AG, Rotkreuz, Switzerland. The modified version in this 510/k) Premarket Notification has the addition of 2 conical shaped 2.9 mm spikes, v.hich are intended to prevent the cerclage band from slipping and give it more stability during the osteointegration period.

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835 Cortez Lane Foster City, CA 94404, USA http://www.hhlconsult.com

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 7 1997

Mr. Hartmut Loch President HHL Consulting Representing PLUS Orthopedics 835 Cortez Lane Foster City, California 94404

Re: K973098 Compression Cerclage Gundolf CCG-GF Trade Name: Requlatory Class: II Product Code: JDQ Dated: August 18, 1997 Received: August 19, 1997

Dear Mr. Loch:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. Hartmut Loch

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D.

Nia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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10/22/1997 18:15 650-572-0901 * ** *** *** *** **

Page 1 __ of ___ 1

510(k) Number (if known): K973098

Device Name: _ Compression Cerclage Gundolf CCG-GF

Indications for Use:

The Compression Cerclage Gundolf CCG is suitable for particular forms of osteosynthesis, particularly for cerclage of the greater trochanter and femur associated with revision hip arthroplasties. In contrast to cerclage wires, the CCG compression band allows a functional compression to be achieved. An assumption is made that an indication for implant revision already exists.

- Reattachment of the greater trochanter. .
- Bone support in case of a damaged proximal femur (e.g. by bone cement, . loosered stem, or polyathylene wear particles), with a possible cancellous bone graft in the proximal femur area.
- Cerclage of bone fissures. ll
- Fracture protection during rasping of a new prosthetic canal and prior to . implaritation of a new stem.
- Closing of a cortical fenestration. .
- Fractures in the area of the femoral stem. 이
- 프 To improve bone-cement interface.

In general, CCG and CCG-GF have the same function. In the case of conical shape of the bone, primarily superior to the lesser trochanter, the CCG-GF is indicated rather than theCCG."

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDEDI

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96