COMPRESSION CERCLAGE GUNDOLF CCG-GF by PLUS ORTHOPEDICS

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.

Device Description

The Compression Cerclage Gundolf CCG-GF is manufactured from 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.

AI/ML Overview

This 510(k) premarket notification (K973098) is for the Compression Cerclage Gundolf CCG-GF. It doesn't contain a detailed study with acceptance criteria and device performance metrics in the way modern AI/software device submissions would.

Instead, this submission is a Substantial Equivalence (SE) determination. This means the device is being compared to a legally marketed predicate device (the CCG Cerclage System, K932024), and the primary "acceptance criteria" revolve around demonstrating that the new device is as safe and effective as the predicate.

Here's a breakdown of why a standard table of acceptance criteria and device performance isn't present, and how to interpret the provided information within the context of a 510(k) submission from 1997:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable in the typical sense for this 510(k) submission. The core "acceptance criteria" for a 510(k) are demonstrating "substantial equivalence" to a predicate device. This is primarily done through a comparison of design, material, strength, indications for use, and contra-indications.
Implied Performance: The submission states that the CCG-GF and the predicate CCG "have the same function" and are "identical in design, material, strength, indications and contra-indications" with the only difference being the addition of 2 conical spikes. The spikes are intended "to prevent the cerclage band from slipping and give it more stability during the osteointegration period." Therefore, the implied performance criterion is that the CCG-GF performs at least as well as the predicate CCG, with a potential improvement in stability due to the spikes.

2. Sample Size Used for the Test Set and Data Provenance:

No specific test set or clinical study is described. For 510(k)s, especially for devices like cerclage systems in 1997, clinical studies were often not required if substantial equivalence could be demonstrated through engineering principles, material properties, and comparison to a predicate device with established clinical use.
Data Provenance: Not applicable, as there's no defined "test set" or clinical data presented for this specific device. The general "provenance" of the predicate device's safety and effectiveness would be its prior market clearance (K932024) and presumably, post-market surveillance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. There is no "test set" and thus no "ground truth" established by experts in the context of a clinical study for this 510(k). The "ground truth" for the predicate device would have been established through its own regulatory clearance and clinical use over time.

4. Adjudication Method for the Test Set:

Not applicable. No test set described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No. This is a hardware orthopedic implant, not an imaging or diagnostic AI device. MRMC studies are not relevant here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

No. This is a hardware orthopedic implant, not an algorithm or AI device.

7. The Type of Ground Truth Used:

Engineering and Material Comparison, and Predicate Device Performance: The primary "ground truth" used for this 510(k) submission is the established safety and effectiveness of the predicate device (CCG Cerclage System, K932024), coupled with engineering and material specifications of the new device that demonstrate its similarity and non-inferiority. The "ground truth" for the predicate device itself would be based on clinical outcomes, surgeon experience, and long-term use data accumulated since its market entry.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/ML device. There is no concept of a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary of the 510(k) Approach:

The K973098 submission for the Compression Cerclage Gundolf CCG-GF demonstrates substantial equivalence by:

Identifying a Predicate Device: The CCG Cerclage System (K932024) sold by Encore Orthopedics, Inc.
Comparing Design, Material, and Function: The submission explicitly states the new device is "identical in design, material, strength, indications and contra-indications" to the predicate.
Highlighting Minor Modification: The only difference is the addition of 2 conical spikes, which are explained as an improvement to prevent slipping and improve stability. This modification is presented as enhancing the device's original function without introducing new risks or changing the fundamental mechanism of action.
Indications for Use: The indications for use are largely identical to the predicate, with a clarification for the CCG-GF in cases of conical bone shapes.

In essence, the "study" proving the device meets "acceptance criteria" is the comparison to the predicate device and the rationale for the minor modification, leveraging the predicate's established history of safety and effectiveness. This is a common pathway for 510(k) clearance, particularly for traditional medical devices with well-understood mechanisms.

Summary

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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.

Page 1 of 2

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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.

Page 2 of 2

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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

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)

Over-The-Counter Use

(Optional Format 1-2-96

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
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.(b)
Classification. Class II.