(69 days)
No
The device description and intended use focus on a mechanical cerclage system made of titanium, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is described for use in osteosynthesis for cerclage of the greater trochanter and femur, specifically to reattach the greater trochanter, support bone in damaged proximal femur, cerclage bone fissures, protect fractures, close cortical fenestrations, and treat fractures in the femoral stem area, all of which aim to treat or alleviate a medical condition.
No
The device description indicates that the Compression Cerclage Gundolf CCG is a surgical implant designed to provide support and compression for bones, particularly in hip revision surgeries. Its intended uses involve reattachment, bone support, and fracture protection, all of which are treatment-oriented functions rather than diagnostic ones. It does not mention any capability of identifying or characterizing diseases or medical conditions.
No
The device description clearly states it is a physical implantable device made of titanium, intended for surgical use. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The Compression Cerclage Gundolf CCG is a surgical implant used to provide mechanical support and compression to bone, specifically in the greater trochanter and femur during revision hip arthroplasties. It is a physical device implanted into the body.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples to diagnose, monitor, or screen for diseases or conditions. Its function is purely structural and mechanical.
Therefore, the Compression Cerclage Gundolf CCG falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / 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, 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.
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."
Product codes
JDQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
greater trochanter, femur, proximal femur, femoral stem
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K.- 932024
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
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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
2 of 2
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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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure. The figure is composed of three overlapping profiles facing to the right, with flowing lines suggesting movement or progress. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the emblem.
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.
3
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
4
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