(27 days)
The SBI Radio-Capitellar implant is indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease including osteo-arthritis or traumatic arthritis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments and devices have failed; and 5) treatment of fractures that are unmanageable using other techniques. The SBI Lateral Assembly Radio-Capitellar implant is intended for cemented use only.
The SBI Lateral Radio Capitellar Implant provides an alternative to hemi-arthroplasty of the proximal radial head. The implant is used for the treatment of degenerative joint disorders of the radio-capitellar joint allowing activities of daily living to be performed with no or significantly reduced pain. The radio-capitellar implant is designed to be used with the radial stem components of the rHead and rHead Recon stem implants cleared for market under 510(k) K011819 and K023604 respectively.
This document is a 510(k) summary for the SBI Lateral Radio Capitellum, an elbow joint prosthesis. It outlines the device's description, intended use, materials, and its substantial equivalence to previously marketed devices. However, it does not contain the information required to answer the questions about acceptance criteria and study details.
The provided text does not include any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (MRMC or standalone). This document is a regulatory submission for premarket notification (510(k)), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against specific acceptance criteria.
Therefore, I cannot provide the requested table and study details based solely on the input given.
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510(k) Summary
| Manufacturer: | rms Company8600 Evergreen BoulevardMinneapolis, MN 55433763-786-1520 - Office763-783-5073FEB 2 1 2007 |
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| Submitted By: | Small Bone Innovations1711 South Pennsylvania AvenueMorrisville, PA 19067 |
| Proprietary Name: | SBI Lateral Radio Capitellum |
| Classification name: | Class II, 888. 3160 - Prosthesis, Elbow, Semi-Constrained,Cemented |
| Common/Usual Name: | Elbow joint metal/polymer semi-constrained cementedprosthesis |
| Substantial Equivalence: | Documentation is provided which demonstrated the SBILateral Radio Capitellum to be substantially equivalent toother legally marketed devices. |
| Device Description: | The SBI Lateral Radio Capitellar Implant provides analternative to hemi-arthroplasty of the proximal radial head.The implant is used for the treatment of degenerative jointdisorders of the radio-capitellar joint allowing activities ofdaily living to be performed with no or significantlyreduced pain. The radio-capitellar implant is designed tobe used with the radial stem components of the rHead andrHead Recon stem implants cleared for market under510(k) K011819 and K023604 respectively. |
| Intended Use: | The SBI Radio-Capitellar implant is indicated for use in theelbow for reduction or relief of pain and/or improved elbowfunction in skeletally mature patients with the followingconditions: 1) non-inflammatory degenerative joint diseaseincluding osteo-arthritis or traumatic arthritis; 2)inflammatory degenerative joint disease includingrheumatoid arthritis; 3) correction of functional deformity;4) revision procedures where other treatments and deviceshave failed; and 5) treatment of fractures that areunmanageable using other techniques. The SBI Lateral |
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K070236 2/2
Assembly Radio-Capitellar implant is intended for cemented use only.
Material:
ASTM F-648: Ultra-High Molecular Weight Polyethylene Powder and Fabricated Form for Surgical Implants. ASTM F-1537: Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants. ASTM F1580: Titanium and Titanium-6Aluminum-4Vanadium Alloy Powders and Coatings of Surgical Implants.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Small Bone Innovations % Mr. Robert Hoehn Regulatory Associate Musculoskeletal Clinical Regulatory Advisers 505 Park Avenue, 14th Floor New York, NY 10022
K070236 Trade/Device Name: SBI Lateral Radio Capitellum Regulation Number: 21 CFR 888.3160 Regulation Name: Elbow joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JDB Dated: January 15, 2007 Received: January 25, 2007
FEB 2 1 2007
Dear Mr. Hoehn:
Re:
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.
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Page 2 - Mr. Robert Hoehn
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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Barbara Buchum
tor
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number: K070236
Device Name: SBI Lateral rHead
Indications For Use:
The Small Bone Innovations' (SBi) Lateral Assembly Radio-Capitellar implant is indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease including osteo-arthritis or traumatic arthritis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments and devices have failed; and 5) treatment of fractures that are unmanageable using other techniques.
The SBi Lateral Assembly Radio-Capitellar implant is intended for cemented use only.
1/1
Prescription Use V (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)
Page 1 of 1
Barbara Becker
(Division Sign-Off) (Division Sign of General, Restorative, ological Devices
510(k) Number K070236
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§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.