(77 days)
No
The device description and performance studies focus on the mechanical properties and design of the plates, with no mention of AI or ML.
Yes.
The device is indicated for wrist arthrodesis, which is a surgical procedure to fuse bones in the wrist, thus providing a therapeutic benefit for conditions requiring joint stabilization.
No
Explanation: The device, APTUS® Wrist Arthrodesis Plates, is described as being used for wrist arthrodesis, which is a surgical procedure to fuse the wrist bones. The device description details its physical characteristics, materials, and surgical application (dorsal or volar approach). This indicates it is an implantable medical device used for treatment, not for diagnosing a condition.
No
The device description clearly details physical plates made of titanium, intended for surgical implantation, and discusses mechanical testing and biocompatibility, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "wrist arthrodesis," which is a surgical procedure to fuse bones in the wrist. This is a direct medical intervention on the body, not a test performed on samples taken from the body.
- Device Description: The device is described as "APTUS® Wrist Arthrodesis Plates," which are physical implants made of titanium. These are surgical implants, not reagents, instruments, or systems used to examine specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
The device is clearly a surgical implant used to stabilize and fuse bones in the wrist. This falls under the category of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
The subject device includes a total of seven (7) plates are to be applied using a dorsal surgical approach, and have an anatomical design appropriate for either the left or right wrist; two (2) plates are to be applied using a volar surgical approach, and are provided in versions designed specifically for the left and right wrist. The dorsal plates have overall lengths ranging from approximately 61 mm to 116 mm, and maximum widths of 13.5 mm. The volar plates have overall lengths ranging from approximately 39 mm to 42 mm, and overall widths ranging from approximately 16 mm to 26 mm. The differences in the Indications for Use Statement for the subject device and the reference devices K 142906 and K042355 include the additional language on the use of the reference devices (fractures and osteotomies) and specific examples of usage (K042355 and K051567). These minor differences do not impact substantial equivalence because all IFUS express equivalent intended use for internal fixation of the bones of the upper extremity.
The plates from the subject device, the primary predicate device, and the reference devices have the same technological characteristics, and have similar design characteristics, include designs for dorsal or volar surgical placement, and include screw holes to accommodate locking and nonlocking screws.
The plates from the subject device, the primary predicate device, and the reference devices encompass a similar range of physical dimensions (overall width, overall length, and thickness). The subject device and the primary predicate device K112169 both include plates with similar anatomic designs for dorsal surgical placement. Similarly, the subject device and the reference device K142906 both include plates with similar anatomic designs for volar surgical placement.
The plates from the subject device, K112169, K142906, and K051567 are manufactured from identical unalloyed titanium material conforming to ASTM F67. The plates from the subject device, K112169, and K 142906 are compatible exclusively with previously cleared Medartis APTUS® screws, and also are compatible with previously cleared Medartis APTUS® K-Wires.
All subject device final, finished components are manufactured in the same facilities using identical materials and identical manufacturing processes as used for the previously cleared Medartis device components (K112169, K142906, and K051567) and, therefore, are substantially equivalent to these devices regarding biocompatibility.
The subject device components and the Medartis device components cleared in K112169 and K142906 are packaged using the same materials, and are to be sterilized by the same methods. Any minor differences in the technological characteristics among the subject device and the devices in K112169 and K142906 do not impact safety or effectiveness.
The differences among the plates from the subject device, the primary predicate device, and the reference devices are variations in the designs of the plates (number of designs, overall dimensions, placement of screw holes), and variations in the sizes of the compatible screws. The plates and screws from the reference device K042355 are made of different materials compared to the subject device. These slight differences among the subject device and the predicate and reference devices do not impact safety or effectiveness.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist
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 testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: biocompatibility referenced from K112169, K142906, and K051567; engineering analysis; mechanical testing according to ASTM F382, and comparative dynamic mechanical testing in a simulated fracture model.
Mechanical performance of the subject device included testing according to ASTM F382 (dorsal plates), and worst-case construct fatigue testing (dorsal plates and volar plates). Based on the results of the testing, the performance of the subject device was judged to be substantially equivalent to the reference devices K142906 and K051567.
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.
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.
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
November 8, 2019
Image /page/0/Picture/1 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Medartis AG % Kevin A. Thomas Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K192297
Trade/Device Name: APTUS Wrist Arthrodesis Plates Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: August 22, 2019 Received: August 23, 2019
Dear Kevin Thomas:
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
1
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 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,
Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
APTUS® Wrist Arthrodesis Plates
Indications for Use (Describe)
APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis.
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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3
510(k) Summary
Medartis AG
APTUS® Wrist Arthrodesis Plates
August 22, 2019
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Medartis AG
Hochbergerstrasse 60E
CH-4057 Basel, Switzerland
Telephone: +41 61 633 34 34
Fax: +41 61 633 34 00 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact | Andrea Kiefer-Schweizer
Head of Quality Management and Regulatory Affairs |
| Representative/Consultant | Kevin A. Thomas, PhD
Floyd G. Larson, MS, MBA
PaxMed International, LLC
12264 El Camino Real, Suite 400
San Diego, CA 92130
Telephone: +1 858-792-1235 |
Fax:
Email:
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | APTUS® Wrist Arthrodesis Plates |
|---|---|
| Common Name | Plate, fixation, bone |
| Classification Name | Single/multiple component metallic bone fixation appliance |
| and accessories | |
| Classification Regulation | 21 CFR 888.3030 |
| Product Code | HRS |
| Classification Panel | Orthopedic |
| Reviewing Office | Office of Health Technology 6 (Orthopedic Devices) |
| Reviewing Division | Division of Health Technology 6 C |
| (Restorative, Repair and Trauma Devices) |
+1 858-792-1236
kthomas(@paxmed.com flarson@paxmed.com
PREDICATE DEVICE INFORMATION
The primary predicate device is K112169, APTUS® Wrist Arthrodesis Plates, Medartis AG.
The reference devices are:
K142906, APTUS® Wrist 2.5 System, Medartis AG; K042355, Synthes (USA) LCP Wrist Fusion Plates, Synthes (USA); and K051567, APTUS® Titanium System, Medartis, Inc.
4
INDICATIONS FOR USE STATEMENT
APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis.
SUBJECT DEVICE DESCRIPTION
The subject device includes a total of seven (7) plates are to be applied using a dorsal surgical approach, and have an anatomical design appropriate for either the left or right wrist; two (2) plates are to be applied using a volar surgical approach, and are provided in versions designed specifically for the left and right wrist. The dorsal plates have overall lengths ranging from approximately 61 mm to 116 mm, and maximum widths of 13.5 mm. The volar plates have overall lengths ranging from approximately 39 mm to 42 mm, and overall widths ranging from approximately 16 mm to 26 mm. The differences in the Indications for Use Statement for the subject device and the reference devices K 142906 and K042355 include the additional language on the use of the reference devices (fractures and osteotomies) and specific examples of usage (K042355 and K051567). These minor differences do not impact substantial equivalence because all IFUS express equivalent intended use for internal fixation of the bones of the upper extremity.
The plates from the subject device, the primary predicate device, and the reference devices have the same technological characteristics, and have similar design characteristics, include designs for dorsal or volar surgical placement, and include screw holes to accommodate locking and nonlocking screws.
The plates from the subject device, the primary predicate device, and the reference devices encompass a similar range of physical dimensions (overall width, overall length, and thickness). The subject device and the primary predicate device K112169 both include plates with similar anatomic designs for dorsal surgical placement. Similarly, the subject device and the reference device K142906 both include plates with similar anatomic designs for volar surgical placement.
The plates from the subject device, K112169, K142906, and K051567 are manufactured from identical unalloyed titanium material conforming to ASTM F67. The plates from the subject device, K112169, and K 142906 are compatible exclusively with previously cleared Medartis APTUS® screws, and also are compatible with previously cleared Medartis APTUS® K-Wires.
All subject device final, finished components are manufactured in the same facilities using identical materials and identical manufacturing processes as used for the previously cleared Medartis device components (K112169, K142906, and K051567) and, therefore, are substantially equivalent to these devices regarding biocompatibility.
The subject device components and the Medartis device components cleared in K112169 and K142906 are packaged using the same materials, and are to be sterilized by the same methods. Any minor differences in the technological characteristics among the subject device and the devices in K112169 and K142906 do not impact safety or effectiveness.
The differences among the plates from the subject device, the primary predicate device, and the reference devices are variations in the designs of the plates (number of designs, overall dimensions, placement of screw holes), and variations in the sizes of the compatible screws. The plates and screws from the reference device K042355 are made of different materials compared to the subject device. These slight differences among the subject device and the predicate and reference devices do not impact safety or effectiveness.
5
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: biocompatibility referenced from K112169, K142906, and K051567; engineering analysis; mechanical testing according to ASTM F382, and comparative dynamic mechanical testing in a simulated fracture model.
Mechanical performance of the subject device included testing according to ASTM F382 (dorsal plates), and worst-case construct fatigue testing (dorsal plates and volar plates). Based on the results of the testing, the performance of the subject device was judged to be substantially equivalent to the reference devices K142906 and K051567.
CONCLUSION
The subject device, the primary predicate device, and the reference device have the same intended use, have similar technological characteristics, and encompass a similar range of physical dimensions appropriate to the anatomy. The subject device and the primary predicate device are made of the identical material. The data included in this submission demonstrate substantial equivalence to the primary predicate device K112169 and reference devices K142906, K042355, and K051567.
6
Table of Substantial Equivalence
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | |
|---|---|---|---|---|---|
| Comparison | APTUS® Wrist Arthrodesis Plates | ||||
| Medartis AG | K112169 | ||||
| APTUS® Wrist Arthrodesis Plates | |||||
| Medartis AG | K142906 | ||||
| APTUS® Wrist 2.5 System | |||||
| Medartis AG | K042355 | ||||
| Synthes (USA) LCP Wrist Fusion Plates | |||||
| Synthes (USA) | K051567 | ||||
| APTUS® Titanium System | |||||
| Medartis, Inc. | |||||
| Indications for Use | |||||
| Statement | APTUS® Wrist Arthrodesis Plates are intended for | ||||
| wrist arthrodesis. | APTUS® Wrist Arthrodesis Plates are intended for | ||||
| wrist arthrodesis. | APTUS® Wrist 2.5 System is intended for use in hand | ||||
| and forearm fractures, osteotomies and arthrodeses. | Synthes (USA) LCP Wrist Fusion Plates are intended | ||||
| for wrist arthrodesis and fractures of other small | |||||
| bones. Specific indications include post-traumatic | |||||
| arthritis of the joints of the wrist; rheumatoid wrist | |||||
| deformities requiring restoration; complex carpal | |||||
| instability; post-septic arthritis of the wrist; severe | |||||
| unremitting wrist pain related to motion; brachial | |||||
| plexus nerve palsies; tumor resection; and spastic | |||||
| deformities. | The APTUS® Titanium Fixation System is intended | ||||
| for use in hand and forearm fractures, osteotomies and | |||||
| arthrodeses. | |||||
| APTUS® Hand group: | |||||
| · Management of the fractures of the distal, middle and | |||||
| proximal phalanges and metacarpals | |||||
| · Management of all types of transversal fractures, | |||||
| spiral fractures, fractures near joints with or without | |||||
| joint involvement, shaft factures, comminuted | |||||
| fractures, dislocation fractures, avulsion fractures | |||||
| • DIP and PIP arthrodeses | |||||
| APTUS® Radius 2.5 group: | |||||
| · Management via radio volar approach of extra- | |||||
| articular extension and flexion fractures, articular | |||||
| extension and flexion fractures, correction osteotomies | |||||
| for badly healed radius fractures | |||||
| · Management via dorsal approach of rare extension | |||||
| fractures that cannot be adequately reduced via volar | |||||
| approach, procedures for which the soft tissue | |||||
| conditions make a volar approach very difficult or | |||||
| impossible, correction osteotomies requiring | |||||
| stabilization from the dorsal side, carporadial fusions. | |||||
| Product Code | HRS | HRS | HRS, HWC | HRS | HRS |
| Intended Use | Internal fixation of the upper extremity | Internal fixation of the upper extremity | Internal fixation of the upper extremity | Internal fixation of the upper extremity | Internal fixation of the upper extremity |
| Reason for | |||||
| Predicate/Reference | |||||
| Device | Not applicable | Identical IFUS; | |||
| Similar plate designs for dorsal surgical placement; | |||||
| Same compatible screws | Similar IFUS: | ||||
| Similar plate designs for volar surgical placement; | |||||
| Same compatible screws | Similar IFUS; | ||||
| Similar plate designs for dorsal surgical placement; | |||||
| Comparison in mechanical testing | Similar IFUS: | ||||
| Similar plate designs for volar surgical placement; | |||||
| Same compatible screws; | |||||
| Comparison in mechanical testing | |||||
| Plates | |||||
| Plate Design | Anatomic plate designs | ||||
| Multiple sizes | |||||
| Multiple designs | |||||
| Designs for dorsal and volar surgical placement | |||||
| Screw holes accommodate locking and non-locking | |||||
| (cortex) screws | Anatomic plate designs | ||||
| Multiple sizes | |||||
| Multiple designs | |||||
| Designs for dorsal surgical placement | |||||
| Screw holes accommodate locking and non-locking | |||||
| (cortex) screws | Anatomic plate designs | ||||
| Multiple sizes | |||||
| Multiple designs | |||||
| Designs for dorsal and volar surgical placement | |||||
| Screw holes accommodate locking and non-locking | |||||
| (cortex) screws | Pre-contoured, limited contact, locking compression | ||||
| plates | |||||
| Designs for dorsal surgical placement | |||||
| Screw holes accommodate locking and non-locking | |||||
| (cortex) screws | Anatomic plate designs (multiple) | ||||
| Multiple sizes | |||||
| Multiple designs | |||||
| Designs for volar and dorsal surgical placement | |||||
| Screw holes accommodate locking and non-locking | |||||
| (cortex) and locking screws | |||||
| Plate Overall | |||||
| Dimensions | |||||
| (Approximate) | Dorsal plates | ||||
| Widths 13.5-15.5 mm, Lengths 61-116 mm | |||||
| Volar plates | |||||
| Widths 16-26 mm, Lengths 39-42 mm | Dorsal plates | ||||
| Widths 17-23 mm, Lengths 59-115 mm | All plates | ||||
| Widths 7-36 mm, Lengths 7-184 mm | 11 mm width | ||||
| (Lengths not stated in 510(k) summary) | All plates | ||||
| Widths 3.2-34 mm, Lengths 18-63 mm | |||||
| Plate Thickness | 1.6 mm to 2.6 mm | 1.8 mm to 2.6 mm | 0.6 mm to 3.2 mm | 3.3 mm | 0.6 mm to 1.6 mm |
| Plate Material | Unalloyed titanium, ASTM F67, grade 4 | Unalloyed titanium, ASTM F67, grade 4 | Unalloyed titanium, ASTM F67, grade 4 | Titanium alloy; stainless steel alloy | Unalloyed titanium, ASTM F67, grade 4 |
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | |
| Comparison | APTUS® Wrist Arthrodesis Plates | ||||
| Medartis AG | K112169 | ||||
| APTUS® Wrist Arthrodesis Plates | |||||
| Medartis AG | K142906 | ||||
| APTUS® Wrist 2.5 System | |||||
| Medartis AG | K042355 | ||||
| Synthes (USA) LCP Wrist Fusion Plates | |||||
| Synthes (USA) | K051567 | ||||
| APTUS® Titanium System | |||||
| Medartis, Inc. | |||||
| Screws | |||||
| Screw Design | Previously cleared Medartis APTUS Screws | ||||
| (K051567, K103332): | |||||
| Locking screws: | |||||
| Cortical thread form, double-lead thread, | |||||
| self-tapping, fully threaded | |||||
| Non-locking screws: | |||||
| Cortical thread form, single-lead thread, | |||||
| self-tapping, fully threaded | Previously cleared Medartis APTUS Screws | ||||
| (K051567, K103332): | |||||
| Locking screws: | |||||
| Cortical thread form, double-lead thread, | |||||
| self-tapping, fully threaded | |||||
| Non-locking screws: | |||||
| Cortical thread form, single-lead thread, | |||||
| self-tapping, fully threaded | Locking screws: | ||||
| Cortical thread form, double-lead thread, | |||||
| self-drilling, self-tapping, fully threaded | |||||
| Non-locking screws: | |||||
| Cortical thread form, single-lead thread, | |||||
| self-drilling, self-tapping, fully threaded | |||||
| Previously cleared Medartis APTUS Screws | |||||
| (K051567, K103332): | |||||
| Locking screws: | |||||
| Cortical thread form, double-lead thread, | |||||
| self-tapping, fully threaded | |||||
| Non-locking screws: | |||||
| Cortical thread form, single-lead thread, | |||||
| self-tapping, fully threaded | Locking screws and cortex (non-locking) screws | Locking screws: | |||
| Cortical thread form, double-lead thread, | |||||
| self-tapping, fully threaded | |||||
| Non-locking screws: | |||||
| Cortical thread form, single-lead thread, | |||||
| self-tapping, fully threaded | |||||
| Screw Diameter | Previously cleared: | ||||
| 2.5 mm (locking and non-locking) | Previously cleared: | ||||
| 2.5 mm (locking and non-locking) | Previously cleared: | ||||
| 1.5 mm and 2.5 mm | 2.7 mm and 3.5 mm (locking and non-locking) | 1.2 mm to 2.5 mm | |||
| Screw Length | Previously cleared: | ||||
| 8 mm to 24 mm (non-locking) | |||||
| 8 mm to 34 mm (locking) | Previously cleared: | ||||
| 8 mm to 34 mm (locking and non-locking) | Previously cleared: | ||||
| Various lengths | 2.7 mm Ø: 10 mm to 24 mm | ||||
| 3.5 mm Ø: 12 mm to 28 mm | |||||
| (From product labeling, not stated in 510(k) | |||||
| Summary) | 4 mm to 34 mm | ||||
| Screw Material | Previously cleared: | ||||
| Ti-6Al-4V alloy, ASTM F136 | Previously cleared: | ||||
| Ti-6Al-4V alloy, ASTM F136 | Previously cleared: | ||||
| Ti-6Al-4V alloy, ASTM F136 | Titanium alloy, stainless steel alloy | ||||
| (From product labeling, not stated in 510(k) | |||||
| Summary) | Ti-6Al-4V alloy, ASTM F136 | ||||
| K-Wires | |||||
| Design | Previously cleared Medartis APTUS K-Wires | ||||
| (K092038): | |||||
| Ø 1.6 mm | Previously cleared Medartis APTUS K-Wires | ||||
| (K092038): | |||||
| Ø 1.6 mm | Previously cleared Medartis APTUS K-Wires | ||||
| (K092038): | |||||
| Ø 1.6 mm | |||||
| Material | Previously cleared: | ||||
| Stainless steel alloy, ASTM F138 | Previously cleared: | ||||
| Stainless steel alloy, ASTM F138 | Previously cleared: | ||||
| Stainless steel alloy, ASTM F138 | |||||
| How Provided | |||||
| Sterility | Provided non-sterile | Provided non-sterile | Provided non-sterile | Not stated in 510(k) Summary | Provided non-sterile |
| Sterilization | End user to sterilize by moist heat | End user to sterilize by moist heat | End user to sterilize by moist heat | Not stated in 510(k) Summary | End user to sterilize by moist heat |
| Usage | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use |
7