(294 days)
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No
The device description is solely focused on the physical characteristics of the screws and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
No.
The device is a series of titanium alloy screws used for fixation of fractures and arthrodesis, which are structural implants and not designed for therapeutic purposes in the sense of delivering treatment or therapy.
No
Explanation: The device description indicates it is a series of titanium screws used for fixing fractures or arthrodesis, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a series of titanium alloy screws, which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The provided description clearly states the device is a series of titanium alloy screws used for surgical fixation of bones (fractures and arthrodesis).
- Intended Use: The intended use is for surgical procedures to stabilize bones in specific anatomical locations.
This device is a surgical implant used for orthopedic procedures, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
The Resch Fixation Screws are intended to be used for Fractures or Arthrodesis of Carpals and Metacarpals, Radial Head and Radial Styloid Fractures, Metatarsal Fractures and Osteotomies of the Forefoot, and Intra-articular arthrodesis in the wrist.
Product codes (comma separated list FDA assigned to the subject device)
OR(87) HRS
Device Description
The Resch Fixation Screw is a series of titanium allov screws, commercially pure or TMZF allov, available in a 2.7mm diameter and lengths of 10mm to 40mm. The screws are available with or without washers(used to prevent the head of the screw from sinking into osteoporotic bone), and are cannulated, fully threaded, and self-tapping.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Carpals, Metacarpals, Radial Head, Radial Styloid, Metatarsal, Forefoot, Wrist
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
FEB - 6 1997
K961498
510(k) Summary
Proprietary Name: Resch Fixation Screw
Small Bone Screw System Common Name:
Classification Name and Reference: 21 CFR 888.3030 Single/Multiple Component Metallic Bone Fixation Appliances and Accessories
Proposed Regulatory Class: Class II Device Product Code: OR(87) HRS
For information contact: Frank Maas Manager, Regulatory Affairs Howmedica Inc. 359 Veterans Boulevard Rutherford, NJ 07070 Telephone: (201) 507-7875 Fax: (201) 507-6870 Date Summary Prepared: 11-15-96
The Resch Fixation Screw is a series of titanium allov screws, commercially pure or TMZF allov, available in a 2.7mm diameter and lengths of 10mm to 40mm. The Resch Fixation Screws are intended to be used for Fractures or Arthrodesis of Carpals and Metacarpals, Radial Head and Radial Styloid Fractures, Metatarsal Fractures and Osteotomies of the Forefoot, and Intra-articular arthrodesis in the wrist. The screws are available with or without washers(used to prevent the head of the screw from sinking into osteoporotic bone), and are cannulated, fully threaded, and self-tapping.
The substantial equivalence of the Resch Fixation Screw is based on an equivalence in design, materials, intended use, and operational principles to Synthes' 3.0mm & 3.5mm Cannulated Screw Systems, Alphatec's Mini Lag Screw System, and Howmedica's Alta Modular Small Bone Plating System and Cfx Intramedullary Rod and Screw System.