(77 days)
APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis.
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 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.
The provided document is a 510(k) summary for a medical device (APTUS® Wrist Arthrodesis Plates), asserting its substantial equivalence to previously marketed predicate devices. This type of regulatory submission does not involve clinical studies to prove acceptance criteria in the way an AI/ML medical device would. Instead, it relies on non-clinical testing (e.g., mechanical, biocompatibility) and a comparison of technological characteristics to already cleared devices.
Therefore, most of the requested information regarding acceptance criteria and performance proven by a study (especially sample sizes, expert ground truth, adjudication, MRMC studies, standalone algorithm performance, and training data details) is not applicable to this type of device submission.
However, I can extract the relevant information regarding the non-clinical testing and "acceptance criteria" (which in this context refers to demonstrating comparable performance to predicates), and present it in a modified format.
Based on the provided 510(k) summary for the APTUS® Wrist Arthrodesis Plates, the following information can be extracted regarding its "acceptance criteria" and "study" (non-clinical testing) that proves the device meets these criteria:
This submission is a 510(k) premarket notification for a bone fixation appliance, and as such, the "acceptance criteria" and "study" differ significantly from those for an AI/ML-driven medical device. The primary goal is to demonstrate substantial equivalence to predicate devices through non-clinical testing and comparison of characteristics, rather than proving a specific diagnostic accuracy or clinical outcome through a traditional clinical trial.
1. Table of Acceptance Criteria and the Reported Device Performance
For this mechanical device, "acceptance criteria" are implicitly met if the device's performance is comparable or superior to its predicates in specified non-clinical tests, and its technological characteristics and intended use are substantially equivalent.
| Acceptance Criterion (Implied) | Reported Device Performance / Evaluation Method |
|---|---|
| Biocompatibility: Device material is safe for human contact. | Referenced from predicate devices K112169, K142906, and K051567. The subject device components are manufactured from identical unalloyed titanium material conforming to ASTM F67, using identical materials and manufacturing processes as the previously cleared Medartis device components. Therefore, it is judged to be substantially equivalent regarding biocompatibility. |
| Mechanical Performance (Strength & Durability): Device maintains structural integrity under simulated physiological loads. | Non-clinical testing included: • ASTM F382 (Standard Specification for Metallic Bone Plates): Applied to dorsal plates. • Comparative Dynamic Mechanical Testing: Performed in a simulated fracture model (worst-case construct fatigue testing) for both dorsal and volar plates. Results: "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." No specific quantitative performance metrics (e.g., force limits, cycles to failure) are provided in this summary, but the conclusion of substantial equivalence implies acceptable performance relative to the predicates. |
| Design Characteristics: Similar anatomical fit and functional features. | The device has similar design characteristics to predicates, including designs for dorsal or volar surgical placement, and screw holes to accommodate locking and non-locking screws. Minor differences in specific dimensions or screw hole placement for new plates were assessed not to impact safety or effectiveness. |
| Material Composition: Compatible and safe materials. | Plates are manufactured from identical unalloyed titanium material conforming to ASTM F67, as used in predicate devices K112169, K142906, and K051567. Screws are made of previously cleared Ti-6Al-4V alloy, ASTM F136. |
| Sterilization: User-level sterilization methods are effective and safe. | Packaged using the same materials and sterilized by the same methods as clear Medartis device components (K112169 and K142906). Provided non-sterile, with the end-user instructed to sterilize by moist heat. |
| Intended Use: Device performs its stated function. | The subject device and the primary predicate device (K112169) share identical Indications for Use: "APTUS® Wrist Arthrodesis Plates are indicated for wrist arthrodesis." Though other reference devices have broader indications (e.g., fractures, osteotomies), the core "internal fixation of the upper extremity" is shared across all, and these minor differences were deemed not to impact substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in terms of human subjects or clinical data for performance evaluation. For mechanical testing, the "sample size" would refer to the number of physical device units tested according to ASTM standards. This information is typically detailed in the full test report, not usually in the 510(k) summary.
- Data Provenance: Not applicable in the context of clinical data for acceptance criteria. The data comes from non-clinical bench testing of the physical device and a comparison of engineering specifications and materials to predicate devices. No human subject data (retrospective or prospective) is mentioned for this type of submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. As this is a mechanical device submission, there is no "ground truth" in the clinical sense established by human experts for a test set. Substantial equivalence is based on engineering principles, material science, and a comparison to already cleared devices.
4. Adjudication Method for the Test Set
- Not Applicable. There is no "adjudication" in the context of human interpretation or clinical data for this type of device submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- Not Applicable. MRMC studies are typically performed for diagnostic imaging devices where human reader performance is being evaluated, particularly with AI assistance. This device is a passive implantable fixation plate.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This is a mechanical implant, not an AI algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance evaluation is established through recognized industry standards (e.g., ASTM F382) for mechanical testing and material specifications (e.g., ASTM F67, ASTM F136). The performance is compared to that of legally marketed predicate devices, implying that their demonstrated safety and effectiveness serve as benchmarks for the subject device.
8. The Sample Size for the Training Set
- Not Applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8.
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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
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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
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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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510(k) Summary
Medartis AG
APTUS® Wrist Arthrodesis Plates
August 22, 2019
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Medartis AGHochbergerstrasse 60ECH-4057 Basel, SwitzerlandTelephone: +41 61 633 34 34Fax: +41 61 633 34 00 |
|---|---|
| Official Contact | Andrea Kiefer-SchweizerHead of Quality Management and Regulatory Affairs |
| Representative/Consultant | Kevin A. Thomas, PhDFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone: +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 applianceand 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.
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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.
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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.
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Table of Substantial Equivalence
| Subject Device | Primary Predicate Device | Reference Device | Reference Device | Reference Device | |
|---|---|---|---|---|---|
| Comparison | APTUS® Wrist Arthrodesis PlatesMedartis AG | K112169APTUS® Wrist Arthrodesis PlatesMedartis AG | K142906APTUS® Wrist 2.5 SystemMedartis AG | K042355Synthes (USA) LCP Wrist Fusion PlatesSynthes (USA) | K051567APTUS® Titanium SystemMedartis, Inc. |
| Indications for UseStatement | APTUS® Wrist Arthrodesis Plates are intended forwrist arthrodesis. | APTUS® Wrist Arthrodesis Plates are intended forwrist arthrodesis. | APTUS® Wrist 2.5 System is intended for use in handand forearm fractures, osteotomies and arthrodeses. | Synthes (USA) LCP Wrist Fusion Plates are intendedfor wrist arthrodesis and fractures of other smallbones. Specific indications include post-traumaticarthritis of the joints of the wrist; rheumatoid wristdeformities requiring restoration; complex carpalinstability; post-septic arthritis of the wrist; severeunremitting wrist pain related to motion; brachialplexus nerve palsies; tumor resection; and spasticdeformities. | The APTUS® Titanium Fixation System is intendedfor use in hand and forearm fractures, osteotomies andarthrodeses.APTUS® Hand group:· Management of the fractures of the distal, middle andproximal phalanges and metacarpals· Management of all types of transversal fractures,spiral fractures, fractures near joints with or withoutjoint involvement, shaft factures, comminutedfractures, dislocation fractures, avulsion fractures• DIP and PIP arthrodesesAPTUS® Radius 2.5 group:· Management via radio volar approach of extra-articular extension and flexion fractures, articularextension and flexion fractures, correction osteotomiesfor badly healed radius fractures· Management via dorsal approach of rare extensionfractures that cannot be adequately reduced via volarapproach, procedures for which the soft tissueconditions make a volar approach very difficult orimpossible, correction osteotomies requiringstabilization 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 forPredicate/ReferenceDevice | 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 designsMultiple sizesMultiple designsDesigns for dorsal and volar surgical placementScrew holes accommodate locking and non-locking(cortex) screws | Anatomic plate designsMultiple sizesMultiple designsDesigns for dorsal surgical placementScrew holes accommodate locking and non-locking(cortex) screws | Anatomic plate designsMultiple sizesMultiple designsDesigns for dorsal and volar surgical placementScrew holes accommodate locking and non-locking(cortex) screws | Pre-contoured, limited contact, locking compressionplatesDesigns for dorsal surgical placementScrew holes accommodate locking and non-locking(cortex) screws | Anatomic plate designs (multiple)Multiple sizesMultiple designsDesigns for volar and dorsal surgical placementScrew holes accommodate locking and non-locking(cortex) and locking screws |
| Plate OverallDimensions(Approximate) | Dorsal platesWidths 13.5-15.5 mm, Lengths 61-116 mmVolar platesWidths 16-26 mm, Lengths 39-42 mm | Dorsal platesWidths 17-23 mm, Lengths 59-115 mm | All platesWidths 7-36 mm, Lengths 7-184 mm | 11 mm width(Lengths not stated in 510(k) summary) | All platesWidths 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 PlatesMedartis AG | K112169APTUS® Wrist Arthrodesis PlatesMedartis AG | K142906APTUS® Wrist 2.5 SystemMedartis AG | K042355Synthes (USA) LCP Wrist Fusion PlatesSynthes (USA) | K051567APTUS® Titanium SystemMedartis, Inc. |
| Screws | |||||
| Screw Design | Previously cleared Medartis APTUS Screws(K051567, K103332):Locking screws:Cortical thread form, double-lead thread,self-tapping, fully threadedNon-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 threadedNon-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 threadedNon-locking screws:Cortical thread form, single-lead thread,self-drilling, self-tapping, fully threadedPreviously cleared Medartis APTUS Screws(K051567, K103332):Locking screws:Cortical thread form, double-lead thread,self-tapping, fully threadedNon-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 threadedNon-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 mm3.5 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 |
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Table of Substantial Equivalence
APTUS® Wrist Arthrodesis Plates K192297 - Page 5 of 5
§ 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.