(86 days)
The OrthoSolutions 'System26' cannulated screws (headed and headless compression) and washers are indicated for use over a guide pin or wire for aligned bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw. Washers of matching size to the headed cannulated bone screw may be used in certain applications for deficient osteopenic bone. The non-cannulated 2.0 (headed, headless compression and Twist-Off) bone screws are applicable, as well, for bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw.
'System26' non-cannulated 2.0mm (headed, headless compression and Twist-Off) bone screws and cannulated (headed and headless compression) bone screw sizes of 2.0mm, 2.5mm 3.0mm are indicated for treating small bone fractures as well as performing osteotomies, arthrodesis and joining cancellous bone fragments in the upper and lower limb and extremities.
'System26' cannulated bone screw sizes (headless compression and headed with optional matching washer) of 4.0mm, 5.0mm, 6.5mm, and 8.0mm are indicated to be used with large and long bones. Specific indications, which are dependent in part on the diameter of the screw include: Minimally invasive bone fracture/joint reconstructions; Additive osteosynthesis for complex joint fractures; Multiple-fragment joint fractures; Femoral neck and femoral head fractures; Femoral supracondylar fractures; Tibial plateau fractures; Fractures of the head of the humerus; Fractures of the tibia; Cooper fractures of the tibia; Bone fractures of the radius, wrist, ankle, elbow, and shoulder; Ligament fixation of the proximal humerus; Bone fractures of the acetabulum and dorsal pelvic ring; Condylar fractures; Ligament avulsion injuries; Malleolar and navicular fractures; Bone fractures of the calcaneus and talus; Arthrodesis of the ankle joint; Arthrodesis of foot joints and; Avulsion fractures.
The OrthoSolutions ‘System26’ Bone Screws are not intended for spinal use.
OrthoSolutions 'System26' Bone Screws are comprised of noncannulated/cannulated bone screws and washers manufactured from Titanium Alloy (to ISO 5832-3/ASTM F136) for implantation within the human body. The instrumentation is made from medical grades of stainless steel and silicon. The 'System26' implants are threaded screws offered in both a 'headed' and 'headless compression' design. The implant screws are available in a range of diameter sizes between 2mm thru 8mm, (each identified with a Type III color anodising) with lengths between 10mm (shortest length) and 120mm (longest length). The implant screw devices (headed with washers and headless compression) and associated instrumentation are available in specifically designed, modular trays and are provided 'Non-sterile' to the end user for 'Single Use'. The 'System26' instruments include guide wires and size specific guides, drill bits and size specific guides, tissue protectors, depth gauges, countersinks, screw driver shafts, ratcheting screw driver handles and bone distractors. These instruments are used to ensure correct positioning and placement of the screws.
The provided text is a 510(k) Summary for the OrthoSolutions 'System26' Bone Screws. It describes the device, its intended use, and argues for its substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.
The document is for a traditional medical device (bone screws), not an AI/ML-driven device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test/training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, are not applicable to this submission.
The "study that proves the device meets the acceptance criteria" mentioned in the document is an "Engineering Analysis" to demonstrate "Substantial Equivalence (SE)" to predicate devices. This type of analysis typically involves comparing material properties, geometric dimensions, mechanical testing results (if applicable), and intended use of the new device against the predicate devices. It does not involve performance metrics like sensitivity, specificity, or AUC that would be seen in an AI/ML device study.
Therefore, I cannot provide the requested information for an AI/ML device based on the provided text.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 8, 2017 Ortho Solutions UK Limited Mr. Al Lippincott U.S. Agent and Official Correspondent to Ortho Solutions UK Limited Engineering Consulting Services, Inc. 3150 E. 200th St. Prior Lake, Minnesota 55372
Re: K163489
Trade/Device Name: OrthoSolutions 'System 26' Bone Screws 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 30, 2016 Received: December 12, 2016
Dear Mr. Al Lippincott:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
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) K163489
Device Name
OrthoSolutions 'System26' Bone Screws
Indications for Use (Describe)
The OrthoSolutions 'System26' cannulated screws (headed and headless compression) and washers are indicated for use over a guide pin or wire for aligned bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw. Washers of matching size to the headed cannulated bone screw may be used in certain applications for deficient osteopenic bone. The non-cannulated 2.0 (headed, headless compression and Twist-Off) bone screws are applicable, as well, for bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw.
'System26' non-cannulated 2.0mm (headed, headless compression and Twist-Off) bone screws and cannulated (headed and headless compression) bone screw sizes of 2.0mm are indicated for treating small bone fractures as well as performing osteotomies, arthrodesis and joining cancellous bone fragments in the upper and lower limb and extremities.
'System26' cannulated bone screw sizes (headless compression and headed with optional matching washer) of 4.0mm, 5.0mm, 6.5mm, and 8.0mm are indicated to be used with large and long bones. Specific indications, which are dependent in part on the diameter of the screw include: Minimally invasive bone fracture/joint reconstructions; Additive osteosynthesis for complex joint fractures; Multiple-fragment joint fractures; Femoral neck and femoral head fractures; Femoral supracondylar fractures; Tibial plateau fractures; Fractures of the head of the tibia; Cooper fractures of the tibia; Bone fractures of the radius, wrist, ankle, elbow, and shoulder; Ligament fixation of the proximal humerus; Bone fractures of the acetabulum and dorsal pelvic ring; Condylar fractures; Ligament avulsion injuries; Malleolar and navicular fractures; Bone fractures of the calcaneus and talus; Arthrodesis of the ankle joint; Arthrodesis of foot joints and; Avulsion fractures.
The OrthoSolutions 'System26' Bone Screws are not intended for spinal use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary of Safety and Effectiveness
In Accordance with 21 CFR 807.92 of the Federal Code of Regulations 510(k) Summary
| NAME OF FIRM: | OrthoSolutions UK LimitedWest Station Business ParkSpital RoadMaldonESSEX, CM9 6FFUnited Kingdomwww.orthosolutions.com |
|---|---|
| 510(k) FIRM CONTACT: | Al LippincottEngineering Consulting Services, Inc.3150 E. 200th St.Prior Lake, MN 55372Tel. No. 952-492-5858e-mail: allippincott@msn.com |
| DATE: | February 24, 2017 |
| TRADE NAME: | OrthoSolutions 'System26' Bone Screws |
| COMMON NAME: | Headed and Headless Compression Cannulated Bone Screw & WasherSystem |
| CLASSIFICATION: | Smooth or threaded metallic bone fixation fastener (per21CFR888.3040) Class II – Screw, Fixation, BoneSingle/multiple component metallic bone fixation appliance andaccessories (per 21CFR888.3030) Class II – Washer, Bolt, Nut,Non-Spinal, Metallic |
| DEVICE PRODUCT CODE: | HWC |
| SUBSEQUENT PRODUCT CODE: | HTN |
| SUBSTANTIALLYEQUIVALENT DEVICES | OrthoSolutions - Cannulated Bone Screws & Washers (K110895)OrthoSolutions – TwistFix & Compression Screws (K111678)Vilex - Cannulated Bone Screws (K991197, K014154)Ascent Medical – Cannulated Bone Screws & Washers (K150693)I.T.S. GmbH - HCS Compression Screw (K131722) |
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OrthoSolutions UK Limited - K163489 - 510(k) Summary:
DEVICE DESCRIPTION: OrthoSolutions 'System26' Bone Screws are comprised of noncannulated/cannulated bone screws and washers manufactured from Titanium Alloy (to ISO 5832-3/ASTM F136) for implantation within the human body. The instrumentation is made from medical grades of stainless steel and silicon. The 'System26' implants are threaded screws offered in both a 'headed' and 'headless compression' design. The implant screws are available in a range of diameter sizes between 2mm thru 8mm, (each identified with a Type III color anodising) with lengths between 10mm (shortest length) and 120mm (longest length). The implant screw devices (headed with washers and headless compression) and associated instrumentation are available in specifically designed, modular trays and are provided 'Non-sterile' to the end user for 'Single Use'. The 'System26' instruments include guide wires and size specific guides, drill bits and size specific guides, tissue protectors, depth gauges, countersinks, screw driver shafts, ratcheting screw driver handles and bone distractors. These instruments are used to ensure correct positioning and placement of the screws.
The OrthoSolutions 'System26' cannulated screws (headed & headless INTENDED USE: compression) and washers are indicated for use over a guide pin or wire for aligned bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw. Washers of matching size to the headed cannulated bone screw may be used in certain applications for deficient osteopenic bone. The non-cannulated 2.0 (headed, headless compression and Twist-Off) bone screws are applicable, as well, for bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw.
'System26' non-cannulated 2.0mm (headed, headless compression and Twist-Off) bone screws and cannulated (headed and headless compression) bone screw sizes of 2.0mm, 2.5mm 3.0mm are indicated for treating small bone fractures as well as performing osteotomies, arthrodesis and joining cancellous bone fragments in the upper and lower limb and extremities.
'System26' cannulated bone screw sizes (headless compression and headed with optional matching washer) of 4.0mm, 5.0mm, 6.5mm, and 8.0mm are indicated to be used with large and long bones. Specific indications, which are dependent in part on the diameter of the screw Minimally invasive bone fracture/joint reconstructions; include: Additive osteosynthesis for complex joint fractures; Multiple-fragment joint fractures; Femoral neck and femoral head fractures; Femoral supracondylar fractures; Tibial plateau fractures; Fractures of the head of the humerus; Fractures of the tibia; Cooper fractures of the tibia; Bone fractures of the radius, wrist, ankle, elbow, and shoulder; Ligament fixation of the proximal humerus; Bone fractures of the acetabulum and dorsal pelvic ring; Condylar fractures; Ligament avulsion injuries; Malleolar and navicular fractures; Bone fractures of the calcaneus and talus; Arthrodesis of the ankle joint; Arthrodesis of foot joints and; Avulsion fractures.
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| OrthoSolutions UK Limited - K163489 - 510(k) Summary: | |
|---|---|
| The OrthoSolutions ‘System26’ Bone Screws are not intended forspinal use. | |
| EQUIVALENCE: | The OrthoSolutions ‘System26’ Bone Screws is substantially equivalentto predicate systems. An Engineering Analysis was provided todemonstrate Substantial Equivalence (SE). |
| SUMMARY OF TECH-NOLOGICAL CHAR-ACTERISTICS: | The OrthoSolutions ‘System26’ Bone Screws is similar in Material,Geometry, Design, and Indications to predicate systems legallymarketed in the US. |
| CONCLUSIONS: | Based on the similarity in Material, Geometry, Design, and Indicationsfor Use, as well as an Engineering Analysis, the OrthoSolutions‘System26’ Bone Screws has been demonstrated to be substantiallyequivalent to the predicate 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.