(237 days)
Not Found
No
The device description focuses solely on the physical components, materials, and intended surgical procedures, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device directly facilitates healing and reconstruction of bones and soft tissues, which aligns with the definition of a therapeutic device.
No
Explanation: The device is described as an "Extremity Fixation Implants for Osteosynthesis System" used to "draw two or more aligned small bone fragments together to facilitate healing" and for "stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction." These are all therapeutic and surgical interventions, not diagnostic activities.
No
The device description clearly outlines various physical implants (plates, screws, staples) made from materials like Titanium and Stainless Steel, along with associated instrumentation. This indicates a hardware-based medical device system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used to physically fix and stabilize bone fragments and soft tissue within the body to facilitate healing. This is a surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The device description details various types of implants (plates, staples, screws) made from materials like titanium and stainless steel, designed for surgical implantation. This aligns with orthopedic fixation devices, not IVDs.
- Anatomical Site: The specified anatomical sites (feet, ankles, toes, hand) are locations within the human body where these implants are surgically placed.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing information for diagnosis, monitoring, or screening.
In summary, the Ortho Solutions Extremity Fixation Implants for Osteosynthesis System is a surgical device used for internal fixation of bones and soft tissues, which falls under the category of medical devices, but not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The intended use of the Ortho Solutions Extremity Fixation Implants for Osteosynthesis System of bundled fixation device(s) is to draw two or more aligned small bone fragments together to facilitate healing. The Ortho Solutions Extremity Fixation Implants for Osteosynthesis System is used in adult patients.
The Ortho Solutions Foot Plating System (FPS) is indicated for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the feet, ankles, and toes skeleton.
The Ortho Solutions Memo Staple System is indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis. The Memo Staple is also indicated for use in fixation of soft tissue to bone such as anterior cruciate reconstruction.
The Ortho Solutions Foot Osteotomy System (FOS) is indicated for alignment and stabilization of small bone fractures including: fixation of small bones, such as those in the foot and ankle for treatment of fractures, non-unions, or mal-unions; ligament reconstructions; osteochondritis dissecans; arthrodesis of the foot and ankle; small bone osteotomies, including first metatarsal head osteotomy and metatarsal osteotomies.
The Ortho Solutions Staples System is indicated for fixation of bone fractures or bone reconstruction. The staples are also indicated for use in fixation of soft tissue to bone.
The Ortho Solutions Compression Screws System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
The Ortho Solutions TwistFix™ Snap-Off Screws System is indicated for fixation of bone fractures or for bone reconstruction. Examples include: 1) Fixation of small bone fragments, 2) Weil Osteotomy, 3) Mono-cortical fixation, and 4) Osteotomies and fractures fixation in the foot and hand.
The Ortho Solutions Extremity Fixation System (EFS) of a low profile head screw is indicated for use in fixation of small bone fractures, nonunions, arthrodesis, and osteotomies of the small bones in the hand or foot.
The Ortho Solutions Extemity Fixation Implants for Osteosynthesis System is not intended for spinal use.
Product codes (comma separated list FDA assigned to the subject device)
HRS, JDR, HWC
Device Description
The Ortho Solutions Extremity Fixation Implants for Osteosynthesis consists of Predicate Trauma Implant components commonly found with large companies with orthopedic markets in the United States. These 'small bone extremity trauma implant devices' consist of the following categories:
- Foot Plating System (FPS)
- Memo Staple System
- Foot Osteotomy System (FOS)
- Staples System
- Compression Screws System
- TwistFix™ Snap-Off Screws System
- Extremity Fixation System (EFS)
A brief and concise description of each system is enclosed as follows:
-
Foot Plating System (FPS): The Ortho Solutions Foot Plating System (FPS) is designed to address a variety of indications in rearfoot, midfoot, and forefoot reconstuctive fixation surgery. The overall system is composed of a smaller 2.7mm and larger 3.5mm locking/nonlocking plating category of system(s). The 2.7mm system of three(3) plate designs consisting of a Universal Locking Plate 2.7 (ULP-2.7), a MetaTarso Phalangeal Plate (MPT), and a Open Wedge Locking Plate (OWL) - all utilized with either a locking or non-locking 2.7mm Screw in various lengths. The 3.5mm system of seven(7) plate designs consisting of a Universal Locking Plate 3.5 (ULP-3.5), a Lapidus Plate(LAP), a Arthrodesis Wedge Plate (AWP), a Rearfoot Reconstuction Plate (RRP), a Tarsal Fusion Plate (TFP), a Calcaneal Step Plate (CSP), and a Calcaneal Locking Plate (CLP) - all utilized with either a locking or non-locking 3.5mm Screw in various lengths. A 3.5mm Cannulated Screw System in various lengths with Washer is also included in the FPS System. Associated instrumentation such as trial plates, disposable drills & wires/guide wires, and ancillary instrumentation is available. All plates, screws, and washer are manufactured from high strength 6-4 Alloyed Titanium to ASTM F136. All plates, screws and washer are offered 'sterile' to the customer.
-
Memo Staple System: The Ortho Solutions Memo Staple System consists of four(4) staple sizes (at 10mm, 12mm, 20mm, and 25mm) manufactured from a Nickel-Titanium Nitinol material according to ASTM 2063 for foot reconstruction fixation/arthrodesis procedures. Only the room temperature superelastic properties of the nitinol material with the use of 'spreader/expander instrumention' is utilized in the surgical procedure to enact compression. Associated instrumentation such as templates, spreaders, expanders, guides, disposable drills and ancillary instrumentation is available. All Memo Staples are offered 'sterile' to the customer.
-
Foot Osteotomy System (FOS): The Ortho Solutions Foot Osteotomy System(FOS) consists of a Nail Plate/Staple with Screws in various lengths and Cannulated/Non-cannulated Compression Screws in various lengths for performing metatarsal/phalangeal osteotomies and/or small bone fixation reconstruction. All components are manufactured from CP Titanium to ASTM F67 and high strength 6-4 Alloyed Titanium to ASTM F136. Associated instrumentation such as guide wires, disposable drills and ancillary instrumentation is available. All staple plate/screw and compression screws are offered 'sterile' to the customer.
-
Staples System: The Ortho Solutions Staples System is composed of a Varisation Staple (smooth), a Compression Varisation Staple (tapered and ribbed), a Compression Staple (in 11mm, 12mm, 13mm, 15mm, and 20mm and width sizes), and a Blount Staple (in 22mm and width sizes) that are barbed/ribbed, angled, and smooth staple components manufactured from high strength 316LVM surgical grade stainless steel material according to ASTM F138. These staple systems are utilized for fixation of bone fractures or bone reconstruction and for fixation of soft tissues. A 'spreader instrument' is used to deform the compression staple diamond shape for bone compression fixation. Associated instrumentation such as spreaders and expanders with disposable drills and ancillary instrumentation is available. All Staples are offered 'sterile' to the customer.
-
Compression Screws System: The Ortho Solutions Compression Screws System consists of Cannulated Meta Compression and Cannulated Compression Screws in various lengths at a diameter of 3.0mm and is used for bone reconstruction in small bone extremities. All compression screws are manufactured from high strength alloyed Titanium to ASTM F136. Associated instumentation such as guide wires and disposable drills and ancillary instrumentation is available. All compression screws are offered 'sterile' to the customer.
-
TwistFix™ Snap-Off Screws System: The Ortho Solutions TwistFix™ Snap-Off Screws System comes in a 2.0mm and 2.5mm diameter with various lengths. All TwistFix™ Snap-Off Screws are manufactured from high strength 6-4 Alloyed Titanium to ASTM F136 and CP Titanium to ASTM F67 and are utilized in metatarsal/ phalangeal small bone fixation/osteotomy procedures. Ancillary instrumentaion with disposable drills is available. All TwistFix™ Snap-Off screws are offered 'sterile' to the customer.
-
Extremity Fixation System (EFS): The Ortho Solutions Extremity Fixation System (EFS) consists of various Cannulated and Non-cannulated Flat Head low profile Fixation Screws in diameter sizes of 2.0mm, 2.4mm, 2.7mm, and 3.5mm, in various lengths and are manufactured from high strength 6-4 Alloyed Titanium material to ASTM F136. These flat head screws allow for a low-profile head-on the cortex bone surface for reduction of tissue irritation. Associated instrumentation such as guide wires, disposable drills and ancillary instrumentation is available. All Flat Head Screws are offered 'sterile' to the customer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
feet, ankles, toes, hand
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Not Found
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)
Not Found
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.
K022325, K022324, K061808, K100359, K070031, K060746, K964226, K061798, K092670, K050681, K043059, K071479, K082320, K050819, K042583, K103705, K963118, K060026
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
§ 888.3030 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
K111678 ('15)
Ortho Solutions Limited - 510(k) Summary: .
510(k) Summary of Safety and Effectiveness
FEB - 7 2012
SAFE MEDICAL DEVICES ACT OF 1990
510(k) Summary
| NAME OF FIRM: | Ortho Solutions Limited
West Station Buisness Park
Spital Road
Maldon
ESSEX, CM9 6FF
United Kingdom |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) FIRM CONTACT: | Al Lippincott
Engineering Consulting Services, Inc.
3150 E. 200th St.
Prior Lake, MN 55372
e-mail: allippincott@msn.com |
| DATE: | April 20, 2011 |
| TRADE NAME: | Ortho Solutions - Extremity Fixation Implants for Osteosynthesis |
| COMMON NAME: | Bone Fixation Plate, Bone Fixation Screw, Cannulated Bone Screw &
Washer, Memory Staple, Bone Screw, Bone Plate, Compression
Screw, Internal Fixation Device (non-spinal), Fixation Staple |
| CLASSIFICATION: | Smooth or threaded metallic bone fixation fastener
(per 21CFR888.3040) - Screw, Fixation, Bone |
| | Single/multiple component metallic bone fixation appliance and
accessories (per 21CFR888.3030) - Plate, Fixation, Bone;
Staple, Fixation, Bone; Washer, Bolt Nut |
| DEVICE PRODUCT CODE: | HRS |
| SUBSEQUENT PRODUCT CODE: | JDR, HWC |
| SUBSTANTIALLY
EQUIVALENT DEVICES | 'Foot Plating System' Ascension Orthopedics (K022325, K022324)
'Foot Plating System' Wright Medical Tech. (K061808, K100359)
'Memo Staple System' Memometal Technologies (K070031)
'Memo Staple System' DePuy Orthopedics (K060746, K964226)
'Memo Staple System' Biopro (K061798)
'Foot Osteotomy System' Biomet/EBI (K092670)
'Foot Osteotomy System' TriMed (K050681)
'Staples System' Wright Medical Tech. (K043059)
'Staples System' Small Bone Innovations (K071479)
'Compression Screws System' Wright Medical Tech. (K082320)
'TwistFix™ Snap-Off Screws System' Wright Medical Tech.
(K050819, K042583)
'Extremity Fixation System' Arthrex (K103705, K963118)
'Extremity Fixation System' Ascension Orthopedics (K060026)
'Extremity Fixation System' Acumed (K963118) |
Page 1 of 5
1
DEVICE DESCRIPTION:
The Ortho Solutions Extremity Fixation Implants for Osteosynthesis consists of Predicate Trauma Implant components commonly found with large companies with orthopedic markets in the United States. These 'small bone extremity trauma implant devices' consist of the following categories:
-
- Foot Plating System (FPS)
-
- Memo Staple System
-
- Foot Osteotomy System (FOS)
-
- Staples System
-
- Compression Screws System
-
- TwistFix™ Snap-Off Screws System
-
- Extremity Fixation System (EFS)
A brief and concise description of each system is enclosed as follows:
-
Foot Plating System (FPS): The Ortho Solutions Foot Plating System (FPS) is designed to address a variety of indications in rearfoot, midfoot, and forefoot reconstuctive fixation surgery. The overall system is composed of a smaller 2.7mm and larger 3.5mm locking/nonlocking plating category of system(s). The 2.7mm system of three(3) plate designs consisting of a Universal Locking Plate 2.7 (ULP-2.7), a MetaTarso Phalangeal Plate (MPT), and a Open Wedge Locking Plate (OWL) - all utilized with either a locking or non-locking 2.7mm Screw in various lengths. The 3.5mm system of seven(7) plate designs consisting of a Universal Locking Plate 3.5 (ULP-3.5), a Lapidus Plate(LAP), a Arthrodesis Wedge Plate (AWP), a Rearfoot Reconstuction Plate (RRP), a Tarsal Fusion Plate (TFP), a Calcaneal Step Plate (CSP), and a Calcaneal Locking Plate (CLP) - all utilized with either a locking or non-locking 3.5mm Screw in various lengths. A 3.5mm Cannulated Screw System in various lengths with Washer is also included in the FPS System. Associated instrumentation such as trial plates, disposable drills & wires/guide wires, and ancillary instrumentation is available. All plates, screws, and washer are manufactured from high strength 6-4 Alloyed Titanium to ASTM F136. All plates, screws and washer are offered 'sterile' to the customer.
-
Memo Staple System: The Ortho Solutions Memo Staple System consists of four(4) staple sizes (at 10mm, 12mm, 20mm, and 25mm) manufactured from a Nickel-Titanium Nitinol material according to ASTM 2063 for foot reconstruction fixation/arthrodesis procedures. Only the room temperature superelastic properties of the nitinol material with the use of 'spreader/expander instrumention' is utilized in the surgical procedure to enact compression.
Page 2 of 5
Section XII
2
Associated instrumentation such as templates, spreaders, expanders, guides, disposable drills and ancillary instrumentation is available. All Memo Staples are offered 'sterile' to the customer.
-
Foot Osteotomy System (FOS): The Ortho Solutions Foot Osteotomy System(FOS) consists of a Nail Plate/Staple with Screws in various lengths and Cannulated/Non-cannulated Compression Screws in various lengths for performing metatarsal/phalangeal osteotomies and/or small bone fixation reconstruction. All components are manufactured from CP Titanium to ASTM F67 and high strength 6-4 Alloyed Titanium to ASTM F136. Associated instrumentation such as guide wires, disposable drills and ancillary instrumentation is available. All staple plate/screw and compression screws are offered 'sterile' to the customer.
-
Staples System: The Ortho Solutions Staples System is composed of a Varisation Staple (smooth), a Compression Varisation Staple (tapered and ribbed), a Compression Staple (in 11mm, 12mm, 13mm, 15mm, and 20mm and width sizes), and a Blount Staple (in 22mm and width sizes) that are barbed/ribbed, angled, and smooth staple components manufactured from high strength 316LVM surgical grade stainless steel material according to ASTM F138. These staple systems are utilized for fixation of bone fractures or bone reconstruction and for fixation of soft tissues. A 'spreader instrument' is used to deform the compression staple diamond shape for bone compression fixation. Associated instrumentation such as spreaders and expanders with disposable drills and ancillary instrumentation is available. All Staples are offered 'sterile' to the customer.
-
Compression Screws System: The Ortho Solutions Compression Screws System consists of Cannulated Meta Compression and Cannulated Compression Screws in various lengths at a diameter of 3.0mm and is used for bone reconstruction in small bone extremities. All compression screws are manufactured from high strength alloyed Titanium to ASTM F136. Associated instumentation such as guide wires and disposable drills and ancillary instrumentation is available. All compression screws are offered 'sterile' to the customer.
-
TwistFix™ Snap-Off Screws System: The Ortho Solutions TwistFix™ Snap-Off Screws System comes in a 2.0mm and 2.5mm diameter with various lengths. All TwistFix™ Snap-Off Screws are manufactured from high strength 6-4 Alloyed Titanium to ASTM F136 and CP Titanium to ASTM F67 and are utilized in metatarsal/ phalangeal small bone fixation/osteotomy procedures. Ancillary instrumentaion with disposable drills is available. All TwistFix™ Snap-Off screws are offered 'sterile' to the customer.
3
K11678(415)
Ortho Solutions Limited - 510(k) Summary: DEVICE DESCRIPTION CONTINUED:
- Extremity Fixation System (EFS): The Ortho Solutions Extremity Fixation System (EFS) consists of various Cannulated and Non-cannulated Flat Head low profile Fixation Screws in diameter sizes of 2.0mm, 2.4mm, 2.7mm, and 3.5mm, in various lengths and are manufactured from high strength 6-4 Alloyed Titanium material to ASTM F136. These flat head screws allow for a low-profile head-on the cortex bone surface for reduction of tissue irritation. Associated instrumentation such as guide wires, disposable drills and ancillary instrumentation is available. All Flat Head Screws are offered 'sterile' to the customer.
INTENDED USE: The intended use of the Ortho Solutions Extremity Fixation Implants for Osteosymthesis System of bundled fixation device(s) is to draw two or more aligned small bone fragments together to facilitate healing. The Ortho Solutions Extremity Fixation Implants for Osteosynthesis System is used in adult patients.
The Ortho Solutions Foot Plating System (FPS) is indicated for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the feet, ankles, and toes skeleton.
The Ortho Solutions Memo Staple System is indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis. The Memo Staple is also indicated for use in fixation of soft tissue to bone such as anterior cruciate reconstruction.
The Ortho Solutions Foot Osteotomy System (FOS) is indicated for alignment and stabilization of small bone fractures including: fixation of small bones, such as those in the foot and ankle for treatment of fractures, non-unions, or mal-unions; ligament reconstructions; osteochondritis dissecans; arthrodesis of the foot and ankle; small bone osteotomies, including first metatarsal head osteotomy and metatarsal osteotomies.
The Ortho Solutions Staples System is indicated for fixation of bone fractures or bone reconstruction. The staples are also indicated for use in fixation of soft tissue to bone.
The Ortho Solutions Compression Screws System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
The Ortho Solutions TwistFix™ Snap-Off Screws System is indicated for fixation of bone fractures or for bone reconstruction. Examples include: 1) Fixation of small bone fragments, 2) Weil Osteotomy, 3) Mono-cortical fixation, and 4) Osteotomies and fractures fixation in the foot and hand.
Page 4 of 5 Section XII
4
Ortho Solutions Limited - 510(k) Summary: INTENDED USE CONTINUED:
The Ortho Solutions Extremity Fixation System (EFS) of a low profile head screw is indicated for use in fixation of small bone fractures, nonunions, arthrodesis, and osteotomies of the small bones in the hand or foot.
The Ortho Solutions Extemity Fixation Implants for Osteosynthesis System is not intended for spinal use.
EQUIVALENCE: The Ortho Solutions Extremity Fixation Implants for Osteosynthesis is substantially equivalent to predicate systems from many orthopedic companies (as listed).
SUMMARY OF TECH-The Ortho Solutions Extremity Fixation Implants for Osteosynthesis NOLOGICAL CHARare identical in Material. Geometry Design/Markings, and Indications ACTERISTICS. to many predicate system marketed and sold in the U.S.
SUMMARY OF SAFETY AND EFFECTIVENESS:
The Ortho Solutions Extremity Fixation Implants for Osteosynthesis is shown to be safe and effective for use as 'sterile' and for single-use in a surgical setting.
Image /page/4/Picture/8 description: The image shows the text "Page 5 of 5" in a bold, slightly distressed font. The words are arranged on a single line, with "Page" on the left, followed by "5 of 5". The text appears to be part of a document or report, indicating that it is the fifth page of a five-page document.
5
Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains an image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are written around the edge of the circle. The eagle is facing to the right and has its head turned to the left.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ortho Solutions, Limited % Engineering Consulting Services, Incorporated Mr. Al Lippincott U.S. Agent and Official Correspondent to Ortho Solutions, Limited 3150 East 200th Street Prior Lake, Minnesota 55372
Re: K111678
Trade/Device Name: Ortho Solutions Extremity Fixation Implants for Osteosynthesis Regulation Number: 21 CFR 888.3030 Regulation Name: Single/ multiple component metallic bone fixation appliance and accessories Regulatory Class: Class II Product Code: HRS, HWC, JDR
Dated: January 18, 2012 Received: January 24, 2012
Dear Mr. 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
FEB - 7 2012
6
Page 2 - Mr. Al Lippincott
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
· Enclosure
7
Image /page/7/Picture/0 description: The image shows the text "ORTHO (S) SOLUTIONS". The letter "S" is inside of a circle. The text is in a sans-serif font and is black.
West Station Business Park, Spital Road, Maldon, Essex CM9 6FF Tel: 0870 7777515 Fax: 0870 7777525 Email: sales@orthosol.com www.orthosolutions.com
Indications for Use
510(k) NUMBER: K111678
DEVICE NAME: Ortho Solutions Extremity Fixation Implants for Osteosynthesis
INDICATIONS FOR USE:
The intended use of the Ortho Solutions Extremity Fixation_ Implants for Osteosynthesis System of bundled fixation device(s) is to draw two or more aligned small bone fragments together to facilitate healing. The Ortho Solutions Extremity Fixation Implants for Osteosynthesis System are used in adult patients.
The Ortho Solutions Foot Plating System (FPS) is indicated for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of the feet, ankles, and toes skeleton.
The Ortho Solutions Memo Staple System is indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis. The Memo Staple is also indicated for use in fixation of soft tissue to bone such as anterior cruciate reconstruction.
The Ortho Solutions Foot Osteotomy System (FOS) is indicated for alignment and stabilization of small bone fractures including: fixation of small bones, such as those in the foot, ankle, and for treatment of fractures, non-unions, or mal-unions, ligament reconstructions; fraotares, more anthrodesis of the foot and ankle; small bone osteotomies, including first metatarsal head osteotomy and metatarsal osteotomies.
8
ORTHO SOLUTIONS
West Station Business Park, Spital Road, Maldon, Essex CM9 6FF Tel: 0870 7777515 Fax: 0870 7777525 Email: sales@orthosol.com www.orthosolutions.com
Indications for Use Continued:
The Ortho Solutions Staples System are indicated for fixation of bone The Ortho Goldtions or bone reconstruction. The staples are also indicated for use in fixation of soft tissue to bone.
The Ortho Solutions Compression Screws System are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
The Ortho Solutions TwistFix™ Snap-Off Screws System are indicated for fixation of bone fractures or for bone reconstruction. Examples include: 1) Fixation of small bone fragments, 2) Weil Osteotomy, 3) Mono-cortical fixation, and 4) Osteotomies and fractures fixation in the foot and hand.
The Ortho Solutions Extremity Fixation System (EFS) of a low profile head screw is indicated for use in fixation of small bone fractures, nonunions, arthrodesis, and osteotomies of the small bones in the hand or foot.
The Ortho Solutions Extremity Fixation Implants for Osteosynthesis System is not intended for spinal use.
Over-The-Counter-Use AND/OR x Prescription Use (21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D) (Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
H.H. for
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
Page | 2 of 2
KIll6781222
Registered Office: West Station Business Park, Spital Road, Maldon, Essex CM9 6FF Registered in England No: 4311933