(38 days)
1.) To fix in place small bony or chondral fragments in the knee and hand where such fragments are not in tension, as in the case of osteochondritis dissecans or fractures of the phalanges and metacarpals;
2.) For fixation of inherently stable osteotomies of the great toe and first metatarsal and intramedullary stabilization of joint arthroplasty (resection) for the treatment of lesser toe deformities.
3.) Used to provide additional support in cases of finger joint fusion and digit replantation where standard fixation or support techniques are also employed.
Biomet OrthoSorb LS resorbable fixation devices include straight and tapered pins. Biomet OrthoSorb LS resorbable fixation devices are made of a resorbable copolymer, polyester derivative of L-lactic and glycolic acids. Poly L-lactic/polyglycolic acid copolymer degrades and resorbs in-vivo by hydrolysis into L-lactic and glycolic acids which are then metabolized by the body.
This is not an AI/ML device, therefore, the requested information is not applicable.
This is a medical device submission for the OrthoSorb LS, a resorbable fixation device (pin) made of a polyester derivative of L-lactic and glycolic acids. The document describes the device, its indications for use, and a summary of substantial equivalence to predicate devices based on mechanical testing.
Here's a breakdown of why an AI/ML device report is not appropriate:
- Device Description: The OrthoSorb LS is a physical pin. AI/ML devices typically refer to software algorithms that perform tasks like image analysis, diagnosis, or prediction.
- Technological Characteristics: The characteristics mentioned are "design, dimensions, and material," which are typical for physical implants.
- Summary of Substantial Equivalence: The equivalence is demonstrated through "mechanical testing that was performed to ASTM D6272" and "Single Shear testing." These are physical tests, not evaluations of algorithmic performance.
- No mention of AI/ML or Software: The document makes no reference to any artificial intelligence, machine learning, software, data processing, or algorithmic components.
Therefore, the requested fields related to acceptance criteria, ground truth, training sets, and expert evaluations for AI/ML performance are not present because the device described is a physical implant, not an AI/ML product.
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APR 1 8 2014
510(k) Summary
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitted by: | Biomet Trauma56 East Bell DrivePO Box 587Warsaw, IN 46581Phone: (574) 372.6801Fax: 574.372.1683 |
|---|---|
| Contact Person: | Victoria Scheitlin, Regulatory Affairs Specialist |
| Date Prepared: | March 2014 |
| Proprietary Name: | OrthoSorb LS |
| Common Name: | Pin, Fixation, Reabsorbable, Hard Tissue |
| Classification Name/ Product Code: | Smooth or threaded metallic bone fixation fastener. (21 CFR§ 888.3040) / OVZ |
| Predicate Devices: | Biomet's OrthoSorb LS is substantially equivalent to thecurrently marketed devices: Depuy's Orthosorb ResorbablePins (K901456 and K111077), and Biomet's LactoSorb BonePin (K990291). |
| Device Description: | Biomet OrthoSorb LS resorbable fixation devices includestraight and tapered pins. Biomet OrthoSorb LS resorbablefixation devices are made of a resorbable copolymer,polyester derivative of L-lactic and glycolic acids. Poly L-lactic/polyglycolic acid copolymer degrades and resorbs in-vivo by hydrolysis into L-lactic and glycolic acids which arethen metabolized by the body. |
| Indications for Use: | 1.) To fix in place small bony or chondral fragments in theknee and hand where such fragments are not in tension, asin the case of osteochondritis dissecans or fractures of thephalanges and metacarpals; |
、
2.) For fixation of inherently stable osteotomies of the great toe and first metatarsal and intramedullary stabilization of
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' joint arthroplasty (resection) for the treatment of lesser toe deformities.
3.) Used to provide additional support in cases of finger joint fusion and digit replantation where standard fixation or support techniques are also employed. \
Technological Characteristics: The technological characteristics of OrthoSorb LS are similar to currently marketed devices including design, dimensions, and material.
Summary of Substantial Equivalence: OrthoSorb LS is substantially equivalent to currently marketed devices demonstrated through mechanical testing that was performed to ASTM D6272, which highlights the method for flexural properties, specifically testing protocol four-point bending. Single Shear testing was also performed which represents a common loading condition observed invivo during which the bone pin is used to fix bony fragments No new issues of safety or efficacy have been raised.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center is a stylized emblem consisting of three abstract shapes that resemble human figures or flowing forms.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 18, 2014
Biomet Trauma Ms. Victoria Scheitlin Regulatory Specialist 56 East Bell Drive Warsaw, Indiana 46581
Re: K140625
Trade/Device Name: OrthoSorb LS Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OVZ Dated: March 7, 2014 Received: March 11, 2014
Dear Ms. Scheitlin:
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. 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 - Ms. Victoria Scheitlin
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportaProblem/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,
Mark N. Melkerson -S
- Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number:
K140625
Device Name:
OrthoSorb LS
Indications For Use:
1.) To fix in place small bony or chondral fragments in the knee and hand where such fragments are not in tension, as in the case of osteochondritis dissecans or fractures of the phalanges and metacarpals;
2.) For fixation of inherently stable osteotomies of the great toe and first metatarsal and intramedullary stabilization of joint arthroplasty (resection) for the treatment of lesser toe deformities.
3.) Used to provide additional support in cases of finger joint fusion and digit replantation where standard fixation or support techniques are also employed.
Prescription Use (Per 21 CFR 801 Subpart D)
AND/OR Over-the-Counter (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
.
Elizabeth L. Erank -S
Division of Orthopedic Devices
§ 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.