(88 days)
Not Found
No
The device description focuses on mechanical components (grips, plates, screws, cables) and manual surgical instrumentation. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are based on mechanical and finite element analyses, not data-driven AI/ML performance metrics.
Yes
The device is intended for the reattachment of the greater trochanter following osteotomy or fracture and for fixation of long bone fractures, which are medical treatments addressing health problems.
No
Explanation: The device is an implantable system (SuperCable™ Grip and Plate System) used for reattaching the greater trochanter or fixing long bone fractures. It provides mechanical fixation and is clearly described as a treatment device, not one that gathers information for diagnosis.
No
The device description explicitly details physical components such as grips, plates, screws, and manual surgical instrumentation made of various metal alloys. It is a hardware-based medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The SuperCable Grip and Plate System is described as a system of implants (grips, plates, screws, cables) and surgical instruments used for fixing bone fractures and reattaching the greater trochanter. These are physical devices implanted into the body during surgery.
- Intended Use: The intended use is for surgical procedures involving bone fixation and reattachment.
- No Mention of Specimens: There is no mention of the device being used to analyze any biological specimens.
Therefore, the SuperCable Grip and Plate System is a surgical implant system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The SuperCable" Grip and Plate System is indicated for use where wire, cable, or band cerclage is used in combination with a trochanteric grip or bone plate. The SuperCable ™ Grip and Plate System is intended to be used in conjunction with the SuperCable™ Iso-Elastic Cerclage System for reattachment of the greater trochanter following osteotomy or fracture, and for fixation of long bone fractures.
Product codes
KTT, HWC, JDQ
Device Description
The SuperCable" Grip and Plate System consists of trochanteric reattachment grips, cable-plates, and cortical bone screws that are intended to be used in conjunction with 1.5mm diameter SuperCable Iso-Elastic Cerclage polymer cables. The cables pass through the grips and plates and provide fixation by attaching these devices to fractured or osteotomized bone fragments. Cortical bone screws may be used in combination with the cable-plates for additional fixation as deemed necessary by the surgeon user. The system includes a range of cable grip, cable-plate, and bone screw sizes and material options, with associated manual surgical instrumentation.
Trochanteric reattachment grips are available in a minimum of four lengths and contain transverse holes for the passage of cables. A cable is passed through the transverse holes and then through its own cable locking clasp, which is part of the cable system. Locking clasps are generally positioned adjacent to the grip on the anterior or posterior surface of the proximal femur. The cable hole exit geometry is designed for optimal cable trajectory and cable contact stress when the grip is affixed to the greater trochanter. Each grip contains two proximal claws that hook into or over the proximal portion of the trochanter fragment and prevent the grip from migrating distally. Each grip also contains two smaller distal claws that penetrate the trochanter fragment distally for additional fixation and stability. The longer grips incorporate an extension to allow for transversely oriented cables around the diaphysis below the lesser trochanter to better resist trochanteric migration or rotation. These longer extensions contain slots for the insertion of compression or locked cortical bone screws into the bone. The grips are available in titanium alloy, cobalt-chromium allov, or stainless steel allov.
Cable-plates are available in a minimum of three lengths and contain transverse holes for the passage of cables. A cable is passed through the transverse plate holes and then through its own cable locking clasp, which is part of the cable system. Locking clasps are generally positioned adjacent to the plate. The plates also contain alternating slots for the insertion of compression or locked cortical bone screws into the bone. By combining locking screw holes with compression slots. the plates can be used as both locking devices and fracture compression devices. The plates resemble standard plates, but have figure-of-eight shaped slots that accommodate standard or locking screws. Thus the plate can be used, depending upon the fracture situation, as a compression plate, a locked internal fixator or as a system combining both techniques. The cable hole exit geometry is designed for optimal contact stress within the cable when the plate is affixed to a long bone. The cable-plates are available in titanium alloy, cobalt-chromium alloy, or stainless steel alloy.
Bone screws are standard self-tapping cortical bone screws and are available in multiple lengths. The screws heads are available in standard compression or locked designs. The bone screws are available in titanium alloy or stainless steel. The product labeling specifies the screw and plate/grip material combinations which may be used together.
Manual instrumentation includes a grip inserter/impactor, drill, depth gage, screwdriver, and sterilization case. All implants are supplied in a non-sterile condition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
greater trochanter, long bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon user
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
The SuperCable Grip and Plate System presents no new risks as compared to the predicate devices. No clinical testing is required for determination of substantial equivalence. The subject devices were found to have greater strength compared to predicate devices based on mechanical and finite element analyses as described in Section 12.11.
Key Metrics
Not Found
Predicate Device(s)
K961267, K972223, K982545, K000734, K001709, K032559, K051986
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
6. 510(k) Summary
| Applicant: | Kinamed, Inc. |
|---|---|
| Address: | 820 Flynn Road, Camarillo, CA 93012 USA |
| Contact person: | Vineet K. Sarin Ph.D. 805-384-2748 (phone), 805-384-2792 (fax) |
| Date prepared: | August 10, 2007 |
| Trade name: | SuperCable™ Grip and Plate System |
Substantial equivalence claimed to (see Section 9.7):
- a) K961267 Pioneer, Greater Trochanter Reattachment Device
- b) K972223 Pioneer, Bone Plate with Cables
- c) K982545 Biomet, BMP Cable System
- d) K000734 Pioneer, Extended Greater Trochanter Reattachment Device
- e) K001709 Pioneer, Trochanteric Reattachment Device
- f) K032559 Synthes, Titanium Locking Screws
- g) K051986-Synthes, LCP Straight Reconstruction Plates
Device Description:
The SuperCable" Grip and Plate System consists of trochanteric reattachment grips, cable-plates, and cortical bone screws that are intended to be used in conjunction with 1.5mm diameter SuperCable Iso-Elastic Cerclage polymer cables. The cables pass through the grips and plates and provide fixation by attaching these devices to fractured or osteotomized bone fragments. Cortical bone screws may be used in combination with the cable-plates for additional fixation as deemed necessary by the surgeon user. The system includes a range of cable grip, cable-plate, and bone screw sizes and material options, with associated manual surgical instrumentation.
Trochanteric reattachment grips are available in a minimum of four lengths and contain transverse holes for the passage of cables. A cable is passed through the transverse holes and then through its own cable locking clasp, which is part of the cable system. Locking clasps are generally positioned adjacent to the grip on the anterior or posterior surface of the proximal femur. The cable hole exit geometry is designed for optimal cable trajectory and cable contact stress when the grip is affixed to the greater trochanter. Each grip contains two proximal claws that hook into or over the proximal portion of the trochanter fragment and prevent the grip from migrating distally. Each grip also contains two smaller distal claws that penetrate the trochanter fragment distally for additional fixation and stability. The longer grips incorporate an extension to allow for transversely oriented cables around the diaphysis below the lesser trochanter to better resist trochanteric migration or rotation. These longer extensions contain slots for the insertion of compression or locked cortical bone screws into the bone. The grips are available in titanium alloy, cobalt-chromium allov, or stainless steel allov.
Cable-plates are available in a minimum of three lengths and contain transverse holes for the passage of cables. A cable is passed through the transverse plate holes and then through its own cable locking clasp, which is part of the cable system. Locking clasps are generally positioned adjacent to the plate. The plates also contain alternating slots for the insertion of compression or
NOV
0 9 2007
1
locked cortical bone screws into the bone. By combining locking screw holes with compression slots. the plates can be used as both locking devices and fracture compression devices. The plates resemble standard plates, but have figure-of-eight shaped slots that accommodate standard or locking screws. Thus the plate can be used, depending upon the fracture situation, as a compression plate, a locked internal fixator or as a system combining both techniques. The cable hole exit geometry is designed for optimal contact stress within the cable when the plate is affixed to a long bone. The cable-plates are available in titanium alloy, cobalt-chromium alloy, or stainless steel alloy.
Bone screws are standard self-tapping cortical bone screws and are available in multiple lengths. The screws heads are available in standard compression or locked designs. The bone screws are available in titanium alloy or stainless steel. The product labeling specifies the screw and plate/grip material combinations which may be used together.
Manual instrumentation includes a grip inserter/impactor, drill, depth gage, screwdriver, and sterilization case. All implants are supplied in a non-sterile condition.
Intended use:
The SuperCable" Grip and Plate System is indicated for use where wire, cable, or band cerclage is used in combination with a trochanteric grip or bone plate. The SuperCable "Grip and Plate System is intended to be used in conjunction with the SuperCable™ Iso-Elastic Cerclage System for reattachment of the greater trochanter following osteotomy or fracture, and for fixation of long bone fractures.
Summary of technological characteristics compared to predicate devices:
The SuperCable Grip and Plate System's material, design, sizing, and indications are identical or similar to the predicate devices. All devices use cables, locking clasps, grips, and bone plates for trochanteric or long bone fracture fixation. All device systems use a tensioning instrument to apply compression and affix the cable to the grip, plate, and bone. Predicate devices are available in titanium alloy, cobalt-chrome alloy, or stainless steel. Predicate systems include grips, plates, and bone screws in a variety of lengths to accommodate common fracture patterns that occur clinically.
Performance Analysis:
The SuperCable Grip and Plate System presents no new risks as compared to the predicate devices. No clinical testing is required for determination of substantial equivalence. The subject devices were found to have greater strength compared to predicate devices based on mechanical and finite element analyses as described in Section 12.11.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 9 2007
Kinamed, Inc. % Vineet K. Sarin, Ph.D. Chief Operating Officer 820 Flynn Road Camarillo, CA 93012
K072250 Re: Trade/Device Name: SuperCable™ Grip and Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code(s): KTT, HWC, JDQ Dated: August 10, 2007 Received: August 13, 2007
Dear Dr. Sarin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2 - Dr. Vineet K. Sarin
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours,
Barbara Buckup for
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
8. Indications for Use
510(k) Number (if known): K07QQ50
Device Name:
SuperCable™ Grip and Plate System
Indications For Use:
The SuperCable" Grip and Plate System is indicated for use where wire, cable, or band cerclage is used in combination with a trochanteric grip or bone plate. The SuperCable™ Grip and Plate System is intended to be used in conjunction with the SuperCable™ Iso-Elastic Cerclage System for reattachment of the greater trochanter following osteotomy or fracture, and for fixation of long bone fractures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
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| 510(k) Number | K072250 |