(52 days)
The Renovis Cannulated Screw System is intended for long and small bone fracture fixation, including: fractures of the tarsals and metatarsal and phalangeal osteotomies; fractures of the carpals and metacarpals; carpal and metacarpal arthrodesis; small fragments of the hand and wrist; ligament fixation as appropriate; sacroiliac joint disruptions; fractures of the distal femur and proximal tibia; intracapsular fractures of the hip; ankle arthrodesis; and pelvis and acetabulum fractures. This system is not indicated for use in the spine.
The Renovis Cannulated Screw System includes cannulated screws and washers, designed to provide secure fixation for various fracture, osteotomy and arthrodesis indications. All screws are cannulated for use over guide pins, allowing for accurate placement. Screws are available in a range of diameters and lengths in partially threaded designs. The system also includes washers to prevent the screw head from pulling through the cortex. The Renovis Cannulated Screw System implants are made from 316L stainless steel.
The provided text describes the Renovis Cannulated Screw System, a bone fixation device. The 510(k) submission states that "No performance testing is included in this application." Therefore, there is no study that proves the device meets acceptance criteria detailed in this document.
The submission focuses on establishing substantial equivalence to a predicate device (Synergy Cannulated Screw System) based primarily on similar intended use, operating principle, design, dimensions, packaging, sterilization directions, and biocompatibility, despite a difference in material composition. The manufacturer justifies this by stating that the use of 316L stainless steel for the Renovis system (compared to the predicate's 23Mn-21Cr-1Mo low nickel stainless steel alloy or Ti-6AL-4V titanium alloy) "does not raise issues of safety or effectiveness."
Given this, the following sections cannot be fully answered as no performance study was conducted.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| None specified | No performance testing was conducted or reported in this submission. |
2. Sample size used for the test set and the data provenance
No test set was used as no performance testing was conducted.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no test set requiring ground truth was used.
4. Adjudication method for the test set
Not applicable, as no test set requiring adjudication was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states, "No performance testing is included in this application."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this device is a physical medical implant (cannulated screw system), not a software algorithm.
7. The type of ground truth used
Not applicable, as no performance testing requiring ground truth was conducted.
8. The sample size for the training set
Not applicable, as this information pertains to machine learning models, and the device is a physical medical implant.
9. How the ground truth for the training set was established
Not applicable, as this information pertains to machine learning models, and the device is a physical medical implant.
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Special 510(k) Summary
| A) Manufacturer: | Renovis Surgical Technologies, LLC1901 W. Lugonia Avenue, Suite 340Redlands, California92374 USATelephone: 909-557-2360Fax: 909-307-8571Contact: Anthony De Benedictis |
|---|---|
| Consultant: | MEDicept, Inc.200 Homer AveAshland, MA 01721Telephone: 508-231-8824Fax: 508-231-8861Contact: F. David Rothkopf |
| B) Device Name | Screw, Fixation, BoneWasher, Bolt Nut |
| Common Name: | Smooth or threaded metallic bone fixation fastenerSingle/multiple component metallic bone fixation appliances andaccessories |
| Proprietary Name: | Renovis Cannulated Screw System |
| Device Regulations: | 21 CFR 888.304021 CFR 888.3030 |
| Class: | II |
| Product Code: | HWCHTN |
| C) Predicates: | K092082 Synergy Cannulated Screw System |
D) Device Description:
The Renovis Cannulated Screw System includes cannulated screws and washers, designed to provide secure fixation for various fracture, osteotomy and arthrodesis indications. All screws are cannulated for use over guide pins, allowing for accurate placement. Screws are available in a range of diameters and lengths in partially threaded designs. The system also includes washers to prevent the screw head from pulling through the cortex. The Renovis Cannulated Screw System implants are made from 316L stainless steel.
November 28, 2011
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E) Intended Use:
The Renovis Cannulated Screw System is intended for long and small bone fracture fixation, including: fractures of the tarsals and metatarsal and phalangeal osteotomies; fractures of the carpals and metacarpals; carpal and metacarpal arthrodesis; small fragments of the hand and wrist; ligament fixation as appropriate; sacroiliac joint disruptions; fractures of the distal femur and proximal tibia; intracapsular fractures of the hip; ankle arthrodesis; and pelvis and acetabulum fractures. This system is not indicated for use in the spine.
| Renovis Cannulated ScrewSystem | Synergy Cannulated ScrewSystem | |
|---|---|---|
| 510K Number | TBD | K092082 |
| Product code | HWC, HTN | HWC, HTN |
| Intended Use/Indication forUse | The Renovis Cannulated ScrewSystem is intended for long andsmall bone fracture fixation,including: fractures of the tarsalsand metatarsals; metatarsal andphalangeal osteotomies;fractures of the carpals andmetacarpals; carpal andmetacarpal arthrodesis; smallfragments ofthe hand and wrist; ligamentfixation as appropriate; sacroiliacjoint disruptions; fractures of thedistal femur and proximal tibia;intracapsular fractures of the hip;ankle arthrodesis; and pelvisand acetabulum fractures. Thissystem is not indicated for use inthe spine. | The Synergy Cannulated ScrewSystem is intended for long andsmall bone fracture fixation,including: fractures of the tarsalsand metatarsals; metatarsal andphalangeal osteotomies;fractures of the carpals andmetacarpals; carpal andmetacarpal arthrodesis; smallfragments ofthe hand and wrist; ligamentfixation as appropriate; sacroiliacjoint disruptions; fractures of thedistal femur and proximal tibia;intracapsular fractures of the hip;ankle arthrodesis; and pelvisand acetabulum fractures. Thissystem is not indicated for use inthe spine. |
| Materialcomposition | 316L stainless steel | 23Mn-21Cr-1Mo low nickelstainless steel alloy orTi-6AL-4V titanium alloy |
| Performancecharacteristics | Same design dimensions; same performance | |
| Sterility | Not provided sterile; sterilize before use; same sterilization directions | |
| Biocompatible | Yes; known | Yes; known |
| Comply with | ASTM F -138 | ASTM F-2229 orASTM F-136 |
F) Comparison to Predicate Device(s):
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Renovis Renovis Cannulated Screw System Special 510(k) Premarket-Notification Submission
Substantial Equivalence Discussion
The Renovis Cannulated Screw System cannulated screws and washers manufactured with 316L stainless steel (316L SS) are substantially equivalent to previously cleared Synergy Cannulated Screw System cannulated screws and washers manufactured with 23Mn-21Cr-1Mo low nickel stainless steel alloy or Ti-6AL-4V titanium alloy. The Renovis Cannulated Screw System manufactured with 316L SS has the following similarities to the predicate device:
- . the same intended use
- the same operating principle ●
- the same design and dimensions ●
- incorporates similar materials ●
- the same packaging ●
- the same sterilization directions .
- is biocompatible ●
Performance
No performance testing is included in this application.
Conformity to Standards
The Renovis Cannulated Screw System conforms to the following standards:
- ASTM 316LVM F-138-00 Standard Specification for Wrought 18Chromium-14Nickel-. 2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
- ISO 17665-1 Sterilization of health care products -- Moist heat -- Part 1: Requirements . for the development, validation, and routine control of a sterilization process for medical devices.
Conclusion
The only difference between the Renovis Cannulated Screw System and the predicate is the grade of stainless steel manufacturing material. The manufacture of the Renovis Cannulated Screw System with 316L SS does not raise issues of safety or effectiveness, and is therefore substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC - 9 2011
Renovis Surgical Technologies, LLC % MEDicent, Inc. Mr. David F. Rothkopf 200 Homer Avenue Ashland, Massachusetts 01721
Re: K113084
Trade/Device Name: Renovis Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC. HTN Dated: November 7, 2011 Received: November 9, 2011
Dear Mr. Rothkopf:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2- Mr. David F Rothkopf
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
B&D Cen Wa
Mark N. Melkers Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Renovis Renovis Cannulated Screw System Special 510(k) Premarket-Notification Submission
Indications for Use
510(k) Number (if known): K113084
Device Name: Renovis Cannulated Screw System
Indications for Use:
The Renovis Cannulated Screw System is intended for long and small bone fracture fixation, including: fractures of the tarsals and metatarsal and phalangeal osteotomies; fractures of the carpals and metacarpals; carpal and metacarpal arthrodesis; small fragments of the hand and wrist; ligament fixation as appropriate; sacroiliac joint disruptions; fractures of the distal femur and proximal tibia; intracapsular fractures of the hip; ankle arthrodesis; and pelvis and acetabulum fractures. This system is not indicated for use in the spine.
Prescription Use _ 21CFR 801, Subpart D OR Over-the-Counter Use _ 21 CFR 876.1500
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division Sign OffOffice of Device Evaluation | (Division Sign-Off)Division of Surgical, Orthopedic,and Restorative Devices |
|---|---|
| 510 (K) | 510(k) Number K113084 |
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.