(86 days)
Not Found
No
The document describes bone screws and associated instrumentation, which are mechanical devices. There is no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is comprised of bone screws and washers intended to repair bone fractures, join bones, and perform osteotomies, which directly treats or alleviates a medical condition.
No
Explanation: This device, the OrthoSolutions 'System26' Bone Screws, is a medical implant used for orthopedic repair (e.g., bone fracture repair, arthrodesis, osteotomy, joint fusion, bone fragment fixation). It is a treatment device, not a diagnostic one.
No
The device description explicitly states that the device is comprised of physical bone screws and washers made from Titanium Alloy, along with associated physical instrumentation made from stainless steel and silicon. There is no mention of any software component.
Based on the provided text, the OrthoSolutions 'System26' bone screws and associated instrumentation are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device as being used for surgical procedures involving bone fracture repair, arthrodesis, osteotomy, joint fusion, and bone fragment fixation. These are all procedures performed directly on the human body.
- Device Description: The device is described as implants (screws and washers) made from titanium alloy for implantation within the human body, along with surgical instruments. This aligns with the description of a surgical device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or examine specimens (like blood, urine, tissue, etc.) outside of the body to provide information about a person's health.
Therefore, the OrthoSolutions 'System26' bone screws and instrumentation are classified as a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
HWC, HTN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and lower limb and extremities, large and long bones, Femoral neck and femoral head, Femoral supracondylar, Tibial plateau, head of the tibia, Bone fractures of the radius, wrist, ankle, elbow, and shoulder, proximal humerus, acetabulum and dorsal pelvic ring, Malleolar and navicular, calcaneus and talus, ankle joint, foot joints.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
An Engineering Analysis was provided to demonstrate Substantial Equivalence (SE).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K110895, K111678, K991197, K014154, K150693, K131722
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.
Not Found
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).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a wing-like shape above them.
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
1
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
2
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 Limited
West Station Business Park
Spital Road
Maldon
ESSEX, CM9 6FF
United Kingdom
www.orthosolutions.com |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) FIRM CONTACT: | Al Lippincott
Engineering Consulting Services, Inc.
3150 E. 200th St.
Prior Lake, MN 55372
Tel. No. 952-492-5858
e-mail: allippincott@msn.com |
| DATE: | February 24, 2017 |
| TRADE NAME: | OrthoSolutions 'System26' Bone Screws |
| COMMON NAME: | Headed and Headless Compression Cannulated Bone Screw & Washer
System |
| CLASSIFICATION: | Smooth or threaded metallic bone fixation fastener (per
21CFR888.3040) Class II – Screw, Fixation, Bone
Single/multiple component metallic bone fixation appliance and
accessories (per 21CFR888.3030) Class II – Washer, Bolt, Nut,
Non-Spinal, Metallic |
| DEVICE PRODUCT CODE: | HWC |
| SUBSEQUENT PRODUCT CODE: | HTN |
| SUBSTANTIALLY
EQUIVALENT 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) |
4
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.
5
| OrthoSolutions UK Limited - K163489 - 510(k) Summary: | |
|---|---|
| The OrthoSolutions ‘System26’ Bone Screws are not intended for | |
| spinal use. | |
| EQUIVALENCE: | The OrthoSolutions ‘System26’ Bone Screws is substantially equivalent |
| to predicate systems. An Engineering Analysis was provided to | |
| demonstrate 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 legally | |
| marketed in the US. | |
| CONCLUSIONS: | Based on the similarity in Material, Geometry, Design, and Indications |
| for Use, as well as an Engineering Analysis, the OrthoSolutions | |
| ‘System26’ Bone Screws has been demonstrated to be substantially | |
| equivalent to the predicate devices. |