(56 days)
Not Found
No
The device description focuses on the mechanical components and materials of the fixation systems, with no mention of software, algorithms, or AI/ML capabilities. The intended use and device description are purely related to physical implants for bone fixation.
Yes.
The device facilitates healing of bone fragments and is indicated for internal fixation and reconstruction of bones, which are therapeutic medical purposes.
No
The device is an orthopedic fixation system designed for internal fixation, reconstruction, and arthrodesis of bones, which is a treatment or surgical device, not a diagnostic one.
No
The device description explicitly details various physical implant components made of titanium (plates and screws) and associated instrumentation. This indicates it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is used to "draw two or more aligned bone fragments together to facilitate healing in an adult patient." This is a therapeutic purpose, directly treating a physical condition (bone fractures and deformities).
- Device Description: The device is described as "extremity trauma implant components" consisting of plates and screws made of titanium. These are physical implants used in surgical procedures.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze samples (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.
- Input Imaging Modality: While x-ray fluoroscopy is mentioned, it's used for guiding the placement of the implants during surgery, not for diagnostic purposes by the device itself.
- Anatomical Site: The device is used on bones, which are part of the patient's body, not on samples taken from the body.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical implant used for treatment.
N/A
Intended Use / Indications for Use
The intended use of the I.T.S. Externity Fixation Systems is to draw two or more aligned bone fragments together to facilitate healing in an adult patient and is composed of the following catagories:
The I.T.S. FLS - Foot Locking Plates System is indicated for use in internal fixation, reconstruction or arthrodesis of small bones including the fore, mid and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and treatment of fractures. Not for spinal use.
The I.T.S. HCS - Headless Compression Screw System for sizes of 3.5mm or smaller is indicated for use in fixation small bone fractures or for small bone reconstruction including; mono or bicortical osteotomies in the foot or hand; distal or proximal metatarsal or metacarpal osteotomies; weil osteotomy; fusion of the first metatarsalphalangeal joint and interphalageal joint; fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.); Akin type osteotomy; distal radius fractures (articular fragments), ulnar styloid fractures, radial head fractures, capitellum fractures, humeral head fractures, glenoid fractures, intercarpal distal and proximal fusions, malleolar fractures, patellar fractures, osteochondral fractures, talonavicular fusions, tibeo-talar fusions, and cuboid fusions.
And for sizes 4.3mm or larger is indicated for use for fractures, corrective osteotomies, pseudoarthrosis, degeneralive transformations of long bones in the hindfoot and large bone intra-articular fractures of the humerus, femur, and tibia. The size of the chosen compression screw should be adapted to the specific indication. Not for spinal use
The I.T.S. HOL – Hallyx Osteotomy Locking Plate System is indicated for use as an intramedullary self-locking plate for distal metatarsal osteotomies and for Hallux Valgus osteotomies up to a corrective angle of 25°. Not for spinal use.
The I.T.S. Twist-Off Screw System is indicated for use for small bone fixation of bone fractures or for bone reconstruction. Examples include small bone fragments, Weil-Osteotomy, Mono-Cortical fixation, Osteotomies and fractures fixation in the foot and hand. Not for spinal use.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The I.T.S. Extremity Fixation Systems consists of Predicate extremity trauma implant components commonly found with large companies with orthopedic markets in the United States. These 'extremity trauma implant devices' consist of the following categories:
- FLS - Foot Locking Plates System
- HCS - Headless Compression Screw System
- HOL- Hallux Osteotomy Locking Plate
- Twist-Off Screws
A brief and concise description of each system is enclosed as follows:
- FLS - Foot Locking Plates System: The I.T.S. FLS - Foot Locking Plates System is composed of various plate types(13) designed to address a wide variety of indications for fractures in the foot. The overall system is composed of a smaller bone series of locking plates (12 types) utilizing 2.4mm, 2.7mm and 3.0mm locking/non-locking screws and a larger bone calcaneus plate utilizing 3.5mm and 4.2mm locking/non-locking screws. The smaller bone system of twelve(12) plate designs consist of the following: (1) MTP Plate, (2) Curved Plate, (3) Straight Plate, (4) H-Shape Plate, (5) Square Plate, (6) I -- Shape Plate, (7) L-Shape Extended Plate, (8) L-Shape Extended, 1mm Step Plate, (9) L-Shape Extended 45º Plate, (10) T-Shape Plate, (11) T-Shape Extended Plate, and (12) TMT Plate. The larger bone system consists of a (13) Calcaneus Plate. All plate systems are manufactured from Commercially Pure (CP) Titanium material to ASTM F67 and allow for minor intra-operative forming/ contouring by the surgeon to fit the bone anatomy. All screws consist of 6-4 Alloyed Titanium material to ASTM F136. Small holes in the plate allow intermediate 'k-wire' bone fracture segment positioning for reducing and aligning the fracture bone segments while positioning the plate and introduction of multiple sizes of locking/non-locking screws as needed for stabilizing the fracture - when using x-ray fluroscopy. All I.T.S. Plates and Screws are processed with an anodize DOTIZE surface treatment. The low-profile and contoured plate design minimizes soft-tissue irritation for the patient.
Associated instrumentation such as disposable drills, mills & wires/guide wires, and ancillary instrumentation is available. All plates and screws are provided Non-Sterile.
- HCS - Headless Compression Screw System: The I.T.S. HCS - Headless Compression Screw System consists of six(6) sizes of compression screws (in sizes 2.0, 2.5, 3.0, 3.5, 4.3 and large/long bone 7.5mm) for small bone extremity and reconstruction fixation/arthrodesis procedures. All screws consist of a 6-4 Alloyed Titanium material to ASTM F136. All I.T.S. Compression Screws are processed with an anodize DOTIZE surface-treatment.
Associated instrumentation such as disposable wires/guide wires, cannulated spiral drills, countersink drills, and ancillary instrumentation is available. All screws are provided Non-Sterile.
- HOL - Hallux Osteotomy Locking Plate: The I.T.S. HOL -Hallux Osteotomy Locking Plate consists of a Nail Plate in three(3) sizes with Screws in various lengths for Halux and distal metatarsal foot/toe bone deformities. The Nail Plate is manufactured from CP Titanium to ASTM F67 and the Screws from 6-4 Alloyed Titanium to ASTM F136. All I.T.S. Nail Plate and Screws are processed with an anodize DOTIZE surface treatment.
Associated instrumentation such as guide wire, disposable drill, template, insertion/removal and ancillary instrumentation is available. All Plates and Screws are provided Non-Sterile.
- Twist-Off Screws: The I.T.S. Twist-Off Screws consist of a 2.0mm and 2.7mm twist-off shank screws in various lengths. All Turn-Off Screws are manufactured from 6-4 Alloyed Titanium to ASTM F136 and are utilized in metatarsal/phalangeal small bone fixation/osteotomy procedures. All I.T.S. Twist-Off Screws are processed with an anodize DOTIZE surface treatment. All Screws are provided Non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray fluroscopy
Anatomical Site
fore, mid and hind foot and ankle; foot or hand; distal or proximal metatarsal or metacarpal; first metatarsalphalangeal joint and interphalageal joint; distal radius; ulnar styloid; radial head; capitellum; humeral head; glenoid; intercarpal distal and proximal; malleolar; patellar; talonavicular; tibeo-talar; cuboid; humerus, femur, and tibia; distal metatarsal; metatarsal/phalangeal
Indicated Patient Age Range
adult patient
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.
K111678, K060613, K063875, K083447, K090675, K100776, K014154, K070039, K091798, K071639, K052614, K071479, K092670, K070039, K050819, K043583
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
I.T.S. GmbH - 510(k) Summary - __
K131722 page 1 of 4
510(k) Summary of Safety and Effectiveness
SAFE MEDICAL DEVICES ACT OF 1990
510(k) Summary
| NAME OF FIRM: | I.T.S. GmbH
Autal 28
Lassnitzhöehe A – 8301
AUSTRIA
www.its-implant.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 | AUG 07 2013 |
| DATE: | June 10, 2013 | |
| TRADE NAME: | I.T.S. Extremity Fixation Systems | |
| COMMON NAME: | Bone Plate, Bone Screw, Compression Screw - Systems | |
| CLASSIFICATION: | Plate, Fixation, Bone & Screw, Fixation, Bone | |
| | Smooth or threaded metallic bone fixation appliances and
accessories. (see 21 CRF, Sec. 888.3030)
Smooth or threaded metallic bone fixation fastener,
(see 21CFR, Sec. 888.3040). | |
DEVICE PRODUCT CODE:
HRS
HWC
SUBSEQUENT PRODUCT CODE:
SUBSTANTIALLY EQUIVALENT DEVICES Ortho Solutions - Extremity Fixation Implants (K111678) Stryker - Foot Plating Systems (K060613, K063875) Memometal - Anchorage Bone Plate System (K083447) Smith & Nephew - VLP Variable-Angle System (K090675) Synthes - 2.4/2.7mm Variable Angle (VA)-LCP Forefoot / Midfoot System (K100776) Vilex - Cannulated Dual Thread Screws (K014154) Memometal - FIXOS Compression Screws (K070039) Merete Medical - Cannulated HCS Compression Screws (K091798) Integra - QWIX Fixation Screws (K071639) Arthrex - Low Profile Plate and Screw System (K052614) SBI - ForeFIX II (K071479) Biomet - BioDrive Micro Nail Plate (K092670) Memometal - FIXOS Twist-Off Screw (K070039) Wright Medical - Charlotte Snap-Off Screws (K050819, K043583)
I.T.S. Extremity Fixation Systems
Page 1 of 4
,
1
K131722 page 2 of 4
1.T.S. GmbH - 510(k) Summary: DEVICE DESCRIPTION:
The I.T.S. Extremity Fixation Systems consists of Predicate extremity trauma implant components commonly found with large companies with orthopedic markets in the United States. These 'extremity trauma implant devices' consist of the following categories:
-
FLS - Foot Locking Plates System
-
HCS - Headless Compression Screw System
3. HOL- Hallux Osteotomy Locking Plate
4. Twist-Off Screws
A brief and concise description of each system is enclosed as follows:
- FLS - Foot Locking Plates System: The I.T.S. FLS - Foot Locking Plates System is composed of various plate types(13) designed to address a wide variety of indications for fractures in the foot. The overall system is composed of a smaller bone series of locking plates (12 types) utilizing 2.4mm, 2.7mm and 3.0mm locking/non-locking screws and a larger bone calcaneus plate utilizing 3.5mm and 4.2mm locking/non-locking screws. The smaller bone system of twelve(12) plate designs consist of the following: (1) MTP Plate, (2) Curved Plate, (3) Straight Plate, (4) H-Shape Plate, (5) Square Plate, (6) I -- Shape Plate, (7) L-Shape Extended Plate, (8) L-Shape Extended, 1mm Step Plate, (9) L-Shape Extended 45º Plate, (10) T-Shape Plate, (11) T-Shape Extended Plate, and (12) TMT Plate. The larger bone system consists of a (13) Calcaneus Plate. All plate systems are manufactured from Commercially Pure (CP) Titanium material to ASTM F67 and allow for minor intra-operative forming/ contouring by the surgeon to fit the bone anatomy. All screws consist of 6-4 Alloyed Titanium material to ASTM F136. Small holes in the plate allow intermediate 'k-wire' bone fracture segment positioning for reducing and aligning the fracture bone segments while positioning the plate and introduction of multiple sizes of locking/non-locking screws as needed for stabilizing the fracture - when using x-ray fluroscopy. All I.T.S. Plates and Screws are processed with an anodize DOTIZE surface treatment. The low-profile and contoured plate design minimizes soft-tissue irritation for the patient.
Associated instrumentation such as disposable drills, mills & wires/guide wires, and ancillary instrumentation is available. All plates and screws are provided Non-Sterile.
I.T.S. Extremity Fixation Systems
Section XII
2
1.T.S. GmbH - 510(k) Summary: DEVICE DESCRIPTION CONTINUED:
K131722 page 3 of 4
HCS - Headless Compression Screw System: The I.T.S. 2. HCS - Headless Compression Screw System consists of six(6) sizes of compression screws (in sizes 2.0, 2.5, 3.0, 3.5, 4.3 and large/long bone 7.5mm) for small bone extremity and reconstruction fixation/arthrodesis procedures. All screws consist of a 6-4 Alloyed Titanium material to ASTM F136. All I.T.S. Compression Screws are processed with an anodize DOTIZE surface-treatment.
Associated instrumentation such as disposable wires/guide wires, cannulated spiral drills, countersink drills, and ancillary instrumentation is available. All screws are provided Non-Sterile.
- HOL - Hallux Osteotomy Locking Plate: The I.T.S. HOL -Hallux Osteotomy Locking Plate consists of a Nail Plate in three(3) sizes with Screws in various lengths for Halux and distal metatarsal foot/toe bone deformities. The Nail Plate is manufactured from CP Titanium to ASTM F67 and the Screws from 6-4 Alloyed Titanium to ASTM F136. All I.T.S. Nail Plate and Screws are processed with an anodize DOTIZE surface treatment.
Associated instrumentation such as guide wire, disposable drill, template, insertion/removal and ancillary instrumentation is available. All Plates and Screws are provided Non-Sterile.
- Twist-Off Screws: The I.T.S. Twist-Off Screws consist of a 2.0mm and 2.7mm twist-off shank screws in various lengths. All Turn-Off Screws are manufactured from 6-4 Alloyed Titanium to ASTM F136 and are utilized in metatarsal/phalangeal small bone fixation/osteotomy procedures. All I.T.S. Twist-Off Screws are processed with an anodize DOTIZE surface treatment. All Screws are provided Non-sterile.
INTENDED USE:
The intended use of the I.T.S. Extemity Fixation Systems is to draw two or more aligned bone fragments together to facilitate healing in an adult patient and is composed of the following catagories:
The I.T.S. FLS - Foot Locking Plates System is indicated for use in internal fixation, reconstruction or arthrodesis of small bones including the fore, mid and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and treatment of fractures. Not for spinal use.
1.T.S. Extremity Fixation Systems
3
I.T.S. GmbH - 510(k) Summary: INTENDED USE CONTINUED:
The I.T.S. HCS - Headless Compression Screw System for sizes of 3.5mm or smaller is indicated for use in fixation small bone fractures or for small bone reconstruction including: mono or bicortical osteotomies in the foot or hand; distal or proximal metatarsal or metacarpal osteotomies; weil osteotomy; fusion of the first metatarsalphalangeal joint and interphalageal joint; fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.); Akin type osteotomy; distal radius fractures (articular fragments), ulnar styloid fractures, radial head fractures, capitellum fractures, humeral head fractures, glenoid fractures, intercarpal distal and proximal fusions, malleolar fractures, patellar fractures, osteochondral fractures, talonavicular fusions, tibeo-talar fusions, and cuboid fusions. And for sizes 4.3mm or larger is indicated for use for fractures, corrective osteotomies, pseudoarthrosis, degenerative transformations of long bones in the hindfoot and large bone intra-articular fractures of the humerus, femur, and tibia. The size of the chosen compression screw should be adapted to the specific indication. Not for spinal use.
The I.T.S. HOL - Hallux Osteotomy Locking Plate System is indicated for use as an intramedullary self-locking plate for distal metatarsal osteotomies and for Hallux Valgus osteotomies up to a corrective angle of 250. Not for spinal use.
The I.T.S. Twist-Off Screw System is indicated for use for small bone fixation of bone fractures or for bone reconstruction. Examples include small bone fragments, Weil-Osteotomy, Mono-Cortical fixation, Osteotomies and fractures fixation in the foot and hand. Not for spinal use.
The I.T.S. Extremity Fixation Systems are substantially equivalent EQUIVALENCE: to the varoius predicate bone plate and screw systems as listed. No nonclinical testing was used in the determination of substantial equivalence.
SUMMARY OF TECH-NOLOGICAL CHAR-ACTERISTICS
SUMMARY OF SAFETY
The I.T.S. Extremity Fixation Systems are Similar in Material, Geometry Design/Markings, and Indications to predicate system(s) currently sold in the U.S. market.
The I.T.S. Extremity Fixation Systems are shown to be safe and AND EFFECTIVENESS: effective for use in plate and screw fracture fixation of small bones in the foot and hand extremities and screw compression fractures in long/large bones.
I.T.S. Extremity Fixation Systems
Section XII
4
Image /page/4/Picture/12 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, services, and human needs. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2013
I.T.S. GmbH % Engineering Consulting Services. Incorporated Mr. Al Lippincott United States Agent and Official Correspondent to I.T.S. GmbH 3150 East 20010 Street Prior Lake, Minnesota 55372
Re: K131722
Trade/Device Name; I.T.S. Extremity Fixation Systems Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: June 26, 2013 Received: June 28, 2013
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 cnactment date of the Medical Device Amendments, or 10 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 complics 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
5
Page 2 - Mr. Al Lippincott
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 reculation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Erin I. Keith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
510(k) NUMBER: __K131722
DEVICE NAME: I.T.S. Extremity Fixation Systems
The intended use of the I.T.S. Externity Fixation Systems is to draw two or more aligned bone fragments together to facilitate healing in an adult patient and is composed of the following catagories:
The I.T.S. FLS - Foot Locking Plates System is indicated for use in internal fixation, reconstruction or arthrodesis of small bones including the fore, mid and hind foot and ankle. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and treatment of fractures. Not for spinal use.
The I.T.S. HCS - Headless Compression Screw System for sizes of 3.5mm or smaller is indicated for use in fixation small bone fractures or for small bone reconstruction including; mono or bicortical osteotomies in the foot or hand; distal or proximal metatarsal or metacarpal osteotomies; weil osteotomy; fusion of the first metatarsalphalangeal joint and interphalageal joint; fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.); Akin type osteotomy; distal radius fractures (articular fragments), ulnar styloid fractures, radial head fractures, capitellum fractures, humeral head fractures, glenoid fractures, intercarpal distal and proximal fusions, malleolar fractures, patellar fractures, osteochondral fractures, talonavicular fusions, tibeo-talar fusions, and cuboid fusions.
And for sizes 4.3mm or larger is indicated for use for fractures, corrective osteotomies, pseudoarthrosis, degeneralive transformations of long bones in the hindfoot and large bone intra-articular fractures of the humerus, femur, and tibia. The size of the chosen compression screw should be adapted to the specific indication. Not for spinal use
The I.T.S. HOL – Hallyx Osteotomy Locking Plate System is indicated for use as an intramedullary self-locking plate for distal metatarsal osteotomies and for Hallux Valgus osteotomies up to a corrective angle of 25°. Not for spinal use.
The I.T.S. Twist-Off Screw System is indicated for use for small bone fixation of bone fractures or for bone reconstruction. Examples include small bone fragments, Weil-Osteotomy, Mono-Cortical fixation, Osteotomies and fractures fixation in the foot and hand. Not for spinal use.
Prescription Use XXXXX Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________
=
(Per 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices