(140 days)
The OsteoMed ExtremiLOCK Wrist Plating System is indicated for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.
OsteoMed ExtremiLOCK Wrist Plating System implants are intended for single use only.
The OsteoMed ExtremiLOCK Wrist Plating System is a rigid fixation and fusion system consisting of plates and screws in various configurations along with the appropriate instrumentation to facilitate modification and implantation. Plates are anatomically pre-contoured in various shapes and sizes. Screws are provided with variable angle locking and non-locking heads and are either fully threaded or partially threaded in various lengths. These screws are either solid core or cannulated and can be used with or without plates. The system also contains smooth variable angle locking pegs and K-wire implants.
The implants of the OsteoMed ExtremiLOCK Wrist Plating System are made from Titanium per ASTM F-67 (Plates), Titanium Alloy per ASTM F-136 (plates, screws, pegs and washer), and Stainless Steel per ASTM F-138( K-wires). The modifications to the plates include the new material of CP Titanium per ASTM F-67 and the screw modifications include the new dual lead technology. The rest of the system has already been cleared through OsteoMed wrist predicate 510(k) K120015. The modification also introduced new sterile packaging configurations for the implants and disposable instruments. The system instruments included facilitate modification and insertion of the implants.
The provided text describes the OsteoMed ExtremiLOCK Wrist Plating System, a medical device, and the basis for its 510(k) clearance. It does not contain information about a study proving that the device meets acceptance criteria related to a diagnostic or AI-driven system.
The "Performance Characteristics & Testing & Clinical" section explicitly states: "Clinical Testing is not required to support substantial equivalence." Instead, the performance evaluation was based on mechanical strength testing of the plates and screws compared to predicate devices.
Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving a device meets them, as the provided document does not detail such a study in the context of diagnostic performance, AI, or human-in-the-loop improvements. The information requested (acceptance criteria table, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, training set details) is typical for the validation of diagnostic algorithms or AI systems, which is not what this document describes for the OsteoMed ExtremiLOCK Wrist Plating System.
The document focuses on the mechanical and material performance of a bone fixation system, establishing substantial equivalence to existing predicate devices based on:
- Mechanical strength testing: Plates and screws were tested against predicate devices to ensure they met required mechanical strength criteria for their intended use.
- Material comparison: The system uses materials (Titanium, Titanium Alloy, Stainless Steel) per ASTM standards, similar to predicates.
- Design and Technology: Similarities in design, technology (e.g., variable angle locking), and operational principles to predicates.
In summary, the provided text discusses regulatory clearance for a medical device based on non-clinical, mechanical performance comparisons, not a clinical study assessing diagnostic accuracy or AI performance.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
OsteoMed Ms. Piedad Peña Manager, Regulatory Affairs 3885 Arapaho Road Addison, Texas 75001
Re: K152145 Trade/Device Name: OsteoMed ExtremiLOCK Wrist Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, KWC Dated: November 24, 2015 Received: November 25, 2015
Dear Ms. Peña:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education 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
510(k) Number (if known): _ Device Name: OsteoMed ExtremiLOCK Wrist Plating System
Indications for Use:
OsteoMed ExtremiLOCK Wrist Plating System is indicated for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the device. It is intended for use in trauma, general surgery, and reconstructive procedures.
OsteoMed ExtremiLOCK Wrist Plating System implants are intended for single use only.
Prescription Use __X Over-The-Counter Use __ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Image /page/3/Picture/0 description: The image shows the logo for OsteoMed. The logo is in blue and gray, with the word "OSTEOMED" in bold, sans-serif letters. The logo is surrounded by a gray and blue swoosh design. The logo is simple and modern, and it is likely used to represent the company's brand.
510(k) Summary
| Submitter Information | OsteoMed3885 Arapaho RoadAddison, Texas 75001Phone: (972) 677-4600Fax: (972) 677-4601 |
|---|---|
| Contact Person | Mrs. Piedad Peña |
| Date Prepared | July 31, 2015 |
| Proprietary Name: | OSTEOMED EXTREMILOCK WRIST PLATING SYSTEM |
| Common Name: | Wrist Fixation System |
| Classification Name: | 21 CFR 888.3030, Single/multiple component metallic bonefixation appliances and accessories |
| Product Code: | HRS, HWC |
Primary Predicate:
OsteoMed Wrist Plating System, K120015
Classification Name: 21 CFR 888.3030, Single/multiple component metallic bone fixation appliances and accessories; Product Code: HRS, HWC; Class: II
Secondary Predicate:
Synthes 2.4mm VA-LCP Two Column Volar Distal Radius Plate, K083694
Classification Name: 21CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories; Product Code: Product Code HRS, Class: II
3″d Reference Predicate:
OsteoMed Hand Plate and Screw Fixation System, K090522
Classification Name: 21 CFR 888.3030, Single/multiple component metallic bone fixation appliances and accessories; Product Code: HRS, HWC; Class: II
4th Reference Predicate:
OsteoMed Foot Plate and Screw Rigid Fixation System, K091614
Classification Name: 21 CFR 888.3030, Single/multiple component metallic bone fixation appliances and accessories; Product Code: HRS, HWC; Class: II
5th Reference Predicate:
OsteoMed Headless Cannulated Screw, K063298
Classification Name: 21 CFR 888.40, Smooth or threaded metallic bone fixation fastener; Product Code: HWC; Class: II
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| Device Description | The OsteoMed ExtremiLOCK Wrist Plating System is a rigid fixationand fusion system consisting of plates and screws in variousconfigurations along with the appropriate instrumentation to facilitatemodification and implantation. Plates are anatomically pre-contouredin various shapes and sizes. Screws are provided with variable anglelocking and non-locking heads and are either fully threaded orpartially threaded in various lengths. These screws are either solidcore or cannulated and can be used with or without plates. Thesystem also contains smooth variable angle locking pegs and K-wireimplants. |
|---|---|
| Device Description | The implants of the OsteoMed ExtremiLOCK Wrist Plating System aremade from Titanium per ASTM F-67 (Plates), Titanium Alloy per ASTMF-136 (plates, screws, pegs and washer), and Stainless Steel per ASTMF-138( K-wires). The modifications to the plates include the newmaterial of CP Titanium per ASTM F-67 and the screw modificationsinclude the new dual lead technology. The rest of the system hasalready been cleared through OsteoMed wrist predicate 510(k)K120015. The modification also introduced new sterile packagingconfigurations for the implants and disposable instruments.The system instruments included facilitate modification and insertionof the implants. |
| Indications for use/Intended Use | The OsteoMed ExtremiLOCK Wrist Plating System is indicated forfracture fixation, fusion and osteotomies of wrist and other bonesappropriate for the size of the device. It is intended for use in trauma,general surgery and reconstructive procedures.OsteoMed ExtremiLOCK Wrist Plating System implants are intendedfor single use only. |
| PerformanceCharacteristics &Testing & Clinical | Performance: Verification testing was conducted to ensure plates andscrews performed equal or better compared to the predicate devices.The plates were tested against the Synthes Secondary PredicateDevice to ensure the design features and new material met therequired mechanical strength criteria for their intended use. Thescrews with the dual lead technology underwent verificationevaluation to ensure the new design features met the mechanicalstrength criteria for the intended use. The screws were compared totheir respective predicates. |
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Clinical Testing is not required to support substantial equivalence.
- Substantial Equivalence The basis of substantial equivalence for this device, OsteoMed ExtremiLOCK Wrist Plating System, is based on similarities in indications for use, intended use, material, function, performance, design, technology, sterilization, and operational principles to the OsteoMed predicates and Synthes predicate. Performance comparisons were performed which verified that the new plates and screws met required mechanical strength criteria for their intended use compared to the legally marketed predicate devices listed in this OsteoMed has shown that the non-clinical tests summary. demonstrate that the devices are as safe and effective as the predicate devices.
§ 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.