(355 days)
Not Found
No
The device description and intended use are solely focused on mechanical fixation devices (screws and washers) and associated instrumentation. There is no mention of any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
No
The device, consisting of screws and washers, is intended for internal bone fixation (e.g., fracture fixation, arthrodesis, osteotomies), which is a surgical aid rather than a therapeutic treatment in itself according to the provided information.
No
The device descriptions and intended uses clearly state that these are orthopedic fixation devices (screws, washers, etc.) used for surgical procedures like fixation of fractures, arthrodesis, and osteotomies. They do not perform any diagnostic function.
No
The device description explicitly details physical hardware components made of titanium alloy, including screws and washers, intended for surgical implantation. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is an "internal soft tissue fixation device" and a "Cannulated Screw System" intended for "soft tissue fixation to bone," "fixation of small bones," "Arthrodesis," "osteotomies," and "fracture fixation." These are all procedures performed within the body to repair or stabilize bone and tissue.
- Lack of Specimen Analysis: There is no mention of the device being used to analyze any biological specimens taken from the patient.
The device described is a surgical implant used for orthopedic procedures, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
WasherLoc™ and No-Profile Screw and Washer Systems: Soft tissue fixation to bone, specifically during ligament reconstructive procedures.
Biomet Cannulated Screw System: Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in: Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow. Arthrodesis of the foot, wrist and elbow. Small and long bone osteotomies. Fracture fixation of small bones, small bone fragments and long bones. Large Cannulated Screws (5mm and larger in diameter) are intended for use in: Fixation of fractures in long bones and long bone fragments. Long bone osteotomies (femur, tibia, foot, ankle, olecranon). Arthrodesis, and fracture fixation of the foot and ankle, such as Jones fractures of the fifth metatarsal, and Calcaneal fractures. Large Cannulated Screws (6.5mm and larger in diameter) are intended for use in: Slipped capital femoral epiphysis, Pediatric femoral neck fractures, Tibial plateau fractures, SI joint disruptions, Intercondylar femur fractures, Subtalar arthrodesis, Fixation of pelvis and illiosacral joint.
Biomet Headless Compression and Twist-Off Screws: The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.
Product codes (comma separated list FDA assigned to the subject device)
MBI, HWC
Device Description
WasherLoc™ and No-Profile Screw and Washer Systems: The WasherLoc™ and No-Profile Screw and Washer Systems are internal soft tissue fixation devices that aid in arthroscopic and orthopedic reconstructive procedures. The system includes instrumentation allowing for proper preparation and placement of the soft tissue fixation device. The No-Profile Screw and Washer System includes titanium alloy (Ti-6A1-4V) screws and washers in various lengths/sizes. Both 4.5mm and 6.0mm diameter screws in lengths from 24mm to 70mm are available. The No-Profile Washers are available in 14mm, 16mm, and 18mm diameters with and without spikes. The spikes on the washers are not intended for additional fixation as used with the No-Profile screws. The WasherLoc™ Tibial Fixation System includes titanium alloy (Ti-6Al-4V) screws and washers in various lengths and sizes. Both 4.5mm and 6.0mm diameter screws in lengths from 24mm to 60mm are available. The WasherLoc™ Washers are available in 14mm, 16mm, and 18mm diameters with spikes intended for additional fixation.
Biomet Cannulated Screw System: The Biomet Cannulated Screw System is designed for a variety of internal fixation, aiding in the alignment, stabilization, and healing of fractures or osteotomies to the skeletal system. The Biomet Cannulated Screw System has multiple variants included which fluctuate in screw diameters and lengths, and include the associated essential instruments that aid in fracture fixation. The Biomet Cannulated Screw System consists of screw variants, which are available in diameters of 3.0mm, 4.0mm, 5.0mm, 6.5mm, and 8.0mm. Each screw diameter is accompanied by instruments that are designed specifically for a given diameter. Washers are also part of the Biomet Cannulated Screw System and are sized 3.0mm, 4.0mm, 5.0mm, 6.5mm, and 8.0mm to specifically match each screw diameter. The washers are provided to add additional support under the head of the screw in situations where the bone quality is poor. Washers are also utilized for more surface area contact with the bone which needed in order to maintain proper fixation of the fracture or osteotomy.
Biomet Headless Compression and Twist-Off Screws: The Biomet Headless Compression and Twist-Off Screws are used for fixation of bone fractures, fusion of a joint, or bone reconstruction, osteotomies of the mid-foot bones, metatarsals and phalanges of the foot and metacarpals, phalanges and carpals of the hand. The Ti-6Al-4V alloy Biomet Headless Compression and Twist-Off Screws have multiple lengths and diameters associated with the different screws ranging from 2.0 to 3.0mm in diameter and lengths from 8 to 40mm. Both sets of screws will be available in sterile and non-sterile configurations. The screws include the associated essential instruments that aid in fracture fixation. The Biomet Headless Compression Screw is a cannulated headless screw which is inserted below the bone surface. This feature helps to minimize soft tissue irritation by sitting recessed and provides compression due to a dual thread design in the shaft and head. The Biomet Twist-Off Screw is a solid one-piece screw that has a drive shaft that has the ability to connect to a drill or large diameter pin driver. In addition, the screw incorporates a breakaway zone between the head and direct connection that allows the screw to break-off cleanly upon insertion. The Biomet Twist-Off Screw also has compression capabilities with a thread-free segment that achieves compression at the osteotomy site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, patella, ankle, wrist, elbow, femur, tibia, olecranon, SI joint, pelvis, iliosacral joint, mid-foot bones, metatarsal, phalanges, hand, metacarpals, carpals
Indicated Patient Age Range
Not Found
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)
Non-Clinical Tests:
- Cytotoxicity and analytical testing to assess the effects of the REVOX process on Titanium devices. Tests include: process residuals evaluation and analytical tests including ICP-MS to identify metallic residues and nonvolatile compounds.
- Bioburden reduction process assessment for impact to shelf life.
- Sterilization validation to assess sterilization dosage and SAL.
- Bacterial Endotoxin Test (BET) Testing has been performed to establish product nonpyrogenicity.
Clinical Tests: - None provided as a basis for substantial equivalence.
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.
K981967, K122437, K140891, K143188, K190035
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
November 10, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Biomet Inc. Janine Kem Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46581
Re: K193214/S001
Trade/Device Name: WasherLoc™ and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI, HWC Dated: October 20, 2020 Received: October 21, 2020
Dear Ms. Kem:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K193214
Device Name
WasherLoc™ and No-Profile Screw and Washer Systems
Indications for Use (Describe)
Soft tissue fixation to bone, specifically during ligament reconstructive procedures.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K193214
Device Name Biomet Cannulated Screw System
Indications for Use (Describe)
Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in:
-
- Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
-
- Arthrodesis of the foot, wrist and elbow.
-
- Small and long bone osteotomies.
-
- Fracture fixation of small bones, small bone fragments and long bones.
Large Cannulated Screws (5mm and larger in diameter) are intended for use in:
-
- Fixation of fractures in long bones and long bone fragments.
-
- Long bone osteotomies (femur, tibia, foot, ankle, olecranon).
- Arthrodesis, and fracture fixation of the foot and ankle, such as Jones fractures of the fifth metatarsal, and Calcaneal fractures.
Large Cannulated Screws (6.5mm and larger in diameter) are intended for use in:
-
- Slipped capital femoral epiphysis
-
- Pediatric femoral neck fractures
-
- Tibial plateau fractures
-
- SI joint disruptions
-
- Intercondylar femur fractures
-
- Subtalar arthrodesis
-
- Fixation of pelvis and iliosacral joint.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K193214
Device Name
Biomet Headless Compression and Twist-Off Screws
Indications for Use (Describe)
The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
510(k) Summary
In accordance with 21 CFR $807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the WasherLoc™ and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System and Biomet Headless Compression and Twist-Off Screws 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|-----------------|-------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Janine Kem
Regulatory Affairs Specialist
Telephone: (574-371-0578) |
| Date: | November 06, 2020 |
Subject Device:
| Trade Name | Common Name | Classification Name |
|---|---|---|
| WasherLoc™ and No-Profile | ||
| Screw and Washer Systems | Soft Tissue Fixation Devices | • MBI – Fastener Fixation, |
| Nondegradable, Soft Tissue (21 CFR 888.3040) | ||
| • HWC – Screw, Fixation, Bone (21 CFR 888.3040) | ||
| Biomet Cannulated Screw | ||
| System | Screw, Fixation, Bone | • HWC – Screw, Fixation, Bone (21 CFR 888.3040) |
| Biomet Headless | ||
| Compression and Twist-Off | ||
| Screws | Screw, Fixation, Bone | • HWC – Screw, Fixation, Bone (21 CFR 888.3040) |
Predicate Device(s):
| K981967 | WasherLocTM, Biomet Sports Medicine Ligament
Washer, Lo-Profile, Heckman, and Channel
Ligament Screw Systems |
|---------|--------------------------------------------------------------------------------------------------------------------|
| K122437 | WasherLocTM and No-Profile Screw and Washer
Systems |
| K140891 | Biomet Cannulated Screw System |
| K143188 | 3.0mm Biomet Cannulated Screw System |
| K190035 | Headless Compression and Twist-Off Screws |
Purpose and Device
6
Description:
The purpose of this Traditional 510(k) is to move the subject devices from a cold nitric acid bioburden reduction process into a bioburden reduction process using REVOX technology.
WasherLoc™ and No-Profile Screw and Washer Systems
The WasherLoc™ and No-Profile Screw and Washer Systems are internal soft tissue fixation devices that aid in arthroscopic and orthopedic reconstructive procedures. The system includes instrumentation allowing for proper preparation and placement of the soft tissue fixation device.
The No-Profile Screw and Washer System includes titanium alloy (Ti-6A1-4V) screws and washers in various lengths/sizes. Both 4.5mm and 6.0mm diameter screws in lengths from 24mm to 70mm are available. The No-Profile Washers are available in 14mm, 16mm, and 18mm diameters with and without spikes. The spikes on the washers are not intended for additional fixation as used with the No-Profile screws.
The WasherLoc™ Tibial Fixation System includes titanium alloy (Ti-6Al-4V) screws and washers in various lengths and sizes. Both 4.5mm and 6.0mm diameter screws in lengths from 24mm to 60mm are available. The WasherLoc™ Washers are available in 14mm, 16mm, and 18mm diameters with spikes intended for additional fixation.
Biomet Cannulated Screw System
The Biomet Cannulated Screw System is designed for a variety of internal fixation, aiding in the alignment, stabilization, and healing of fractures or osteotomies to the skeletal system. The Biomet Cannulated Screw System has multiple variants included which fluctuate in screw diameters and lengths, and include the associated essential instruments that aid in fracture fixation.
The Biomet Cannulated Screw System consists of screw variants, which are available in diameters of 3.0mm, 4.0mm, 5.0mm, 6.5mm, and 8.0mm. Each screw diameter is accompanied by instruments that are designed specifically for a given diameter. Washers are also part of the Biomet Cannulated Screw System and are sized 3.0mm, 4.0mm, 5.0mm, 6.5mm, and 8.0mm to specifically match each screw diameter. The washers are provided to add additional support under the head of the screw in situations where the bone quality is poor. Washers are also utilized for more surface area contact with the bone which needed in order to maintain proper fixation of the fracture or osteotomy.
Biomet Headless Compression and Twist-Off Screws
The Biomet Headless Compression and Twist-Off Screws are used for fixation of bone fractures, fusion of a joint, or bone reconstruction, osteotomies of the mid-foot bones, metatarsals
7
and phalanges of the foot and metacarpals, phalanges and carpals of the hand. The Ti-6Al-4V alloy Biomet Headless Compression and Twist-Off Screws have multiple lengths and diameters associated with the different screws ranging from 2.0 to 3.0mm in diameter and lengths from 8 to 40mm. Both sets of screws will be available in sterile and non-sterile configurations. The screws include the associated essential instruments that aid in fracture fixation.
The Biomet Headless Compression Screw is a cannulated headless screw which is inserted below the bone surface. This feature helps to minimize soft tissue irritation by sitting recessed and provides compression due to a dual thread design in the shaft and head.
The Biomet Twist-Off Screw is a solid one-piece screw that has a drive shaft that has the ability to connect to a drill or large diameter pin driver. In addition, the screw incorporates a breakaway zone between the head and direct connection that allows the screw to break-off cleanly upon insertion. The Biomet Twist-Off Screw also has compression capabilities with a thread-free segment that achieves compression at the osteotomy site.
Intended Use and Indications for Use:
WasherLoc™ and No-Profile Screw and Washer Systems
Soft tissue fixation to bone, specifically during ligament reconstructive procedures.
Biomet Cannulated Screw System
Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in:
- Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
-
- Arthrodesis of the foot, wrist and elbow.
-
- Small and long bone osteotomies.
- Fracture fixation of small bones, small bone fragments and long bones.
Large Cannulated Screws (5mm and larger in diameter) are intended for use in:
-
- Fixation of fractures in long bones and long bone fragments.
-
- Long bone osteotomies (femur, tibia, foot, ankle, olecranon).
- Arthrodesis, and fracture fixation of the foot and ankle, such as Jones fractures of the fifth metatarsal, and Calcaneal fractures.
Large Cannulated Screws (6.5mm and larger
- in diameter) are intended for use in:
-
- Slipped capital femoral epiphysis
-
- Pediatric femoral neck fractures
8
-
- Tibial plateau fractures
-
- SI joint disruptions
-
- Intercondylar femur fractures
-
- Subtalar arthrodesis
-
- Fixation of pelvis and illiosacral joint.
Biomet Headless Compression and Twist-Off Screws
The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.
Summary of Technological Characteristics:
The rationale for substantial equivalence is based on consideration of the following characteristics:
- . Intended Use: The intended use of the subject devices is the same as the predicate devices.
- Indications for Use: The indications for use of the ● subject devices is similar to the predicate devices.
- . Materials: The materials used in the subject devices are the same as the predicate devices.
- Design Features: The design features of the subject ● devices are similar to the predicate devices.
- Sterilization: The sterilization method of the subject ● devices is the same as the predicate devices.
Summary of Performance Data (Nonclinical and/or Clinical)
● Non-Clinical Tests:
- Cytotoxicity and analytical testing to assess the o effects of the REVOX process on Titanium devices. Tests include: process residuals evaluation and analytical tests including ICP-MS to identify metallic residues and nonvolatile compounds.
- Bioburden reduction process assessment for O impact to shelf life.
- Sterilization validation to assess sterilization O dosage and SAL.
- Bacterial Endotoxin Test (BET) Testing has O been performed to establish product nonpyrogenicity.
9
● Clinical Tests:
- 0 None provided as a basis for substantial equivalence.
Substantial Equivalence Conclusion
The subject devices have been shown to be substantially equivalent to the predicate devices. The proposed subject devices have the same intended use and indications for use as the predicate devices. The proposed devices have similar technological characteristics to the predicates, and the differences do not raise new questions of safety and effectiveness.