(58 days)
The APTUS 3.5 TriLock Straight Plates are intended for the fixation of fractures, osteotomies and non-unions of the scapula, olecranon, radius, ulna, foot, distal tibia and fibula.
The subject device APTUS 3.5 TriLock Straight Plates are available in eleven (11) designs with 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, or 16 screw holes. The plates have an overall length ranging from 32 mm to 200 mm. The subject device plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS System. The subject device plates are compatible with screws and K-wires previously cleared in K193633, K110908, and K092038. The subject device plates are manufactured from titanium alloy conforming to ASTM F136, and are provided non-sterile or sterile to the end user.
This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific aspects like training set, ground truth, expert adjudication, MRMC studies, and standalone performance are not applicable.
The submission focuses on demonstrating "substantial equivalence" to existing legally marketed predicate devices, primarily through non-clinical performance data and comparison of technological characteristics.
Here's a breakdown of the relevant information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a table of explicit acceptance criteria with corresponding performance metrics in the way one might see for an AI/ML diagnostic device with sensitivity/specificity targets. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence through:
- Biocompatibility: Referenced from predicate device K193633. (No specific numerical performance reported for the subject device beyond equivalence).
- Sterilization: Referenced from predicate device K193633 (moist heat for non-sterile, X-ray beam for sterile components). (No specific numerical performance reported for the subject device beyond equivalence).
- Packaging and Sterile Barrier Shelf Life: Referenced from predicate device K193633. (No specific numerical performance reported for the subject device beyond equivalence).
- Mechanical Testing: Performed according to ASTM F382. This standard specifies requirements for metallic bone plates. The document states that mechanical testing was done "according to ASTM F382," implying that the device met the requirements of this standard. No specific numerical performance results (e.g., fatigue life, stiffness) are provided in this summary, but the reference to the standard confirms compliance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (conforming to established standards) | Referenced from predicate device K193633 (substantially equivalent). |
| Sterilization (effective and compliant with methods) | Referenced from predicate device K193633 (substantially equivalent). |
| Packaging and Sterile Barrier Shelf Life (maintaining sterility) | Referenced from predicate device K193633 (substantially equivalent). |
| Mechanical Performance (meeting bone plate standards) | Met requirements of ASTM F382. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable for this type of device submission. Mechanical testing per ASTM F382 would involve a specific number of samples, but the exact number is not detailed in this summary.
- Data Provenance: The data is "non-clinical testing data," meaning it's from laboratory tests, not human subjects. It does not involve patient data or geographical provenance. It is entirely retrospective in the sense that the testing and its results underpin the submission for marketing clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable. This is a medical device for bone fixation, not an AI/ML diagnostic system requiring expert interpretation of images or patient data to establish ground truth.
4. Adjudication Method for the Test Set:
- Not applicable. (See answer to #3).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- Not applicable. This is not an AI/ML device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used:
For the non-clinical performance data, the "ground truth" refers to the established standards and accepted scientific methods:
- Mechanical Testing: The "ground truth" is adherence to the requirements and test methods outlined in ASTM F382.
- Biocompatibility: Adherence to established ISO standards for biocompatibility (referenced implicitly by reliance on the predicate device's clearance).
- Sterilization: Adherence to recognized standards for sterilization methods (e.g., Moist Heat, X-ray beam).
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This is not an AI/ML device.
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June 2, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
Medartis AG % Kevin Thomas, Phd Vice President & Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K230971
Trade/Device Name: APTUS® 3.5 TriLock Straight 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: April 3, 2023 Received: April 5, 2023
Dear Dr. 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 mediation-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-S
Shumaya Ali, M.P.H. Assistant Director DHT6B: 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
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Indications for Use
510(k) Number (if known) K230971
Device Name
APTUS 3.5 TriLock Straight Plates
Indications for Use (Describe)
The APTUS 3.5 TriLock Straight Plates are intended for the fixation of fractures, osteotomies and non-unions of the scapula, olecranon, radius, ulna, foot, distal tibia and fibula.
| 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 3.5 TriLock Straight Plates April 3, 2022
ADMINISTRATIVE INFORMATION
| Manufacturer Name | Medartis AGHochbergerstrasse 60ECH-4057 Basel, SwitzerlandTelephone +41 61 633 34 34Fax +41 61 633 34 00 |
|---|---|
| Official Contact | Claudia De Santis, Head of Regulatory Affairs |
| Representative/Consultant | Kevin A. Thomas, PhDFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130Telephone +1 858-792-1235Fax +1 858-792-1236Email kthomas@paxmed.comflarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | APTUS 3.5 TriLock Straight Plates |
|---|---|
| Common Name | Plate, fixation, bone |
| Regulation Number | 21 CFR 888.3030 |
| Regulation Name | Single/multiple component metallic bone fixation appliances and accessories |
| Regulatory Class | Class II |
| 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) |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K193633, APTUS® Ankle Trauma System 2.8/3.5, Medartis AG
Additional Predicate Devices K082807, Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications, Synthes (USA) K011335, Synthes One-Third Tubular DCL Plate, Synthes (USA) K110908, APTUS® Foot 3.5 System, Medartis AG K193639, APTUS® Foot 2.8-3.5 System, Medartis AG
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The APTUS 3.5 TriLock Straight Plates are intended for the fixation of fractures, osteotomies and non-unions of the scapula, olecranon, radius, ulna, foot, distal tibia and fibula.
SUBJECT DEVICE DESCRIPTION
The purpose of this submission is to obtain marketing clearance for additional plate designs to expand the range of the Medartis APTUS® Ankle Trauma System 2.8/3.5, previously cleared under K193633. The subject device APTUS 3.5 TriLock Straight Plates are available in eleven (11) designs with 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, or 16 screw holes. The plates have an overall length ranging from 32 mm to 200 mm. The subject device plates include screw holes designed to accommodate appropriately sized bone screws and K-wires presently marketed as part of the APTUS System. The subject device plates are compatible with screws and K-wires previously cleared in K193633, K110908, and K092038.
The subject device plates are manufactured from titanium alloy conforming to ASTM F136, and are provided non-sterile or sterile to the end user.
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: biocompatibility referenced from K193633; moist heat sterilization (to be performed by the end user) referenced from K193633; X-ray beam sterilization, packaging, and sterile barrier shelf life referenced from K193633; and mechanical testing according to ASTM F382. Clinical data were not provided in this submission.
EQUIVALENCE TO MARKETED DEVICES
The subject device is substantially equivalent in indications and design principles to the primary predicate device, and the additional predicate devices listed above. Provided at the end of this summary are tables comparing the Indications for Use Statements (IFUS) and the technological characteristics of the subject device, the primary predicate device, and the additional predicate devices.
The Indications for Use Statements (IFUS) for the subject device and the predicate devices listed above include language for fixation of fractures, osteotomies, and non-unions of various bones. The IFUS for the predicate devices K110908 and K193639 do not reference non-unions. The IFUS for the subject device and predicate device K193639 include language that includes use in the foot. The IFUS for the additional predicate devices K082807 and K011335 include language referring to fixation of the pelvis that is not relevant to the subject device. The IFUS for K082807 and K011335 also include language referring to use in osteopenic bone; this language is not included in the IFUS for the subject device. Additionally, the IFUS of the subject device does not list specifically adult patients and pediatric patients as in the predicate device K082807. These minor differences among the IFUS do not impact substantial equivalence because all IFUS express equivalent intended use for internal fixation of bones in various anatomic locations.
The primary predicate K193633 is in support of substantial equivalence in terms of similar plate designs; compatible screw designs; identical plate materials; identical materials for the device-specific (Class II) instruments and accessories; the same sterilization, packaging, and shelf life for product provided sterile to the end user; and the same sterilization for devices provided non-sterile to the end user.
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The plates from the subject device and the primary predicate device K193633 and the additional predicate device K082807 have the same technological characteristics, have similar design characteristics, and include screw holes to accommodate locking and non-locking screws.
The subject device plates are compatible with Medartis screws previously cleared in K110908, including 3.5 TriLock (locking) and cortical (non-locking) screws. The subject device plates also are compatible with Medartis K-Wires previously cleared in K092038, K193633, and K193639.
K082807 and K011335 are in support of substantial equivalence in terms of similar Indications for Use, comparable plate designs (use with locking and non-locking screws), and a similar range of physical dimensions (overall width, overall length). K011335 is also in support of substantial equivalence in terms of comparative mechanical testing.
All subject device final finished components (plates, device-specific instrument templates, and device-specific accessories) are manufactured in the same facilities using identical materials and identical manufacturing processes as used for the primary predicate device K193633, and therefore, are substantially equivalent to these previously-cleared devices regarding biocompatibility.
The subject device components that are provided sterile to the end user are packaged using the same materials, are sterilized by the same method, and have the same sterile barrier shelf life as the Medartis devices in K193633. The subject device components that are provided non-sterile also are packaged using the same materials, and are to be sterilized by the same methods as the Medartis devices in K193633.
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: biocompatibility referenced from K193633; moist heat sterilization (to be performed by the end user) referenced from K193633; X-ray beam sterilization, packaging, and sterile barrier shelf life referenced from K193633; and mechanical testing according to ASTM F382.
CONCLUSION
The subject device, the primary predicate device, and the additional predicate devices have the same intended use, have similar technological characteristics, and are made of identical or similar materials. The subject device, the primary predicate, and the additional predicate devices encompass the same range of physical dimensions, are packaged in similar materials, and are sterilized using similar methods.
The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.
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| Subject Device | Indications for Use Statement |
|---|---|
| APTUS 3.5 TriLock Straight PlatesMedartis AG | The APTUS 3.5 TriLock Straight Plates are intended for the fixation of fractures, osteotomies and non-unions of thescapula, olecranon, radius, ulna, foot, distal tibia and fibula. |
| Primary Predicate Device | |
| K193633APTUS® Ankle Trauma System 2.8/3.5Medartis AG | APTUS® Ankle Trauma System 2.8/3.5 is indicated for fractures, osteotomies, malunions and non-unions of the distal tibia and fibula. |
| Additional Predicate Devices | |
| K082807Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) Systemwith Expanded IndicationsSynthes (USA) | Synthes 3.5 mm Locking Compression Plate (LCP) System:The Synthes 3.5 mm Locking Compression Plate (LCP) System is indicated for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone for adult patients.These plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients. |
| Synthes 4.5 mm Locking Compression Plate (LCP) System:The Synthes 4.5 mm Locking Compression Plate (LCP) System is indicated for fixation of various long bones, such as the humerus, femur and tibia and for use in fixation of peri-prosthetic fractures, osteopenic bone and fixation of non-unions or malunions in adult patients.These plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones. in pediatric patients. | |
| K011335Synthes One-Third Tubular DCL PlateSynthes (USA) | Synthes One-Third Tubular Plate is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone as a part of the Synthes Small Fragment DCL System. |
| K110908APTUS® Foot 3.5 SystemMedartis AG | The APTUS® Foot 3.5 System is indicated for fractures and osteotomies of the calcaneus. |
| K193639APTUS® Foot 2.8-3.5 SystemMedartis AG | The APTUS® Foot System is intended for use in small bones, in particular in fractures, osteotomies and arthrodesis of the tarsals, metatarsals and phalanges. |
Substantial Equivalence – Indications for Use Statement
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| Features / Comparisons | Subject Device | Primary Predicate DeviceK193633 | Additional Predicate DeviceK082807 | Additional Predicate DeviceK011335 | Additional Predicate DeviceK110908 | Additional Predicate DeviceK193639 |
|---|---|---|---|---|---|---|
| Product Code | APTUS 3.5 TriLock Straight Plates | APTUS® Ankle Trauma System2.8/3.5 | Synthes (USA) 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications | Synthes One-Third Tubular DCL Plate | APTUS® Foot 3.5 System | APTUS® Foot 2.8-3.5 System |
| Reason for Predicate/Reference Device | Medartis AG | Medartis AG | Synthes (USA) | Synthes (USA) | Medartis AG | Medartis AG |
| HRS | HRS, HWC, HTN | HRS, HWC | HRS | HRS, HWC | HRS, HWC, PLF | |
| Not applicable | Similar intended use and IFUS; Plate designs, including use with locking and non-locking screws; 3.5 compatible screws; compatible K-wires; identical materials; moist heat sterilization (by end user); x-ray beam sterilization, packaging, sterile barrier shelf life; biocompatibility | Similar intended use and IFUS; Plate designs, including use with locking and non-locking screws; similar range of plate dimensions; similar material; | Similar intended use and IFUS; Plate designs, including use with locking and non-locking screws; similar range of plate dimensions; similar material; comparison mechanical testing | Similar intended use and IFUS; Plate designs, including use with locking and non-locking screws; 3.5 compatible screws | Similar intended use and IFUS; Plate designs, including use with locking and non-locking screws; 3.5 compatible screws | |
| Plate Description | Straight plates with 3.5 TriLock locking; scalloped edge design; rounded ends; 11 sizes | Anatomic plate designs; Multiple designs and sizes; Screw holes accommodate 3.5 TriLock (locking) and non-locking (cortex) screws | Straight plates with locking holes; LCP fixed-angle locking holes; 9 sizes | Locking technology; LCP fixed-angle locking holes | Anatomic plate designs; Multiple designs and sizes; Screw holes accommodate 3.5 TriLock (locking) and non-locking (cortex) screws | Anatomic plate designs; Multiple designs and sizes; Screw holes accommodate 3.5 TriLock (locking) and non-locking (cortex) screws |
| Image: Plate | Image: Plate | Image: Plate | ||||
| Plate Materials | Ti-6Al-4V alloy, ASTM F136 | Ti-6Al-4V alloy, ASTM F136Unalloyed titanium, ASTM F67 | Stainless steel, commercially pure titanium | Stainless steel, commercially pure titanium | Unalloyed titanium, ASTM F67 | Ti-6Al-4V alloy, ASTM F136Unalloyed titanium, ASTM F67 |
| Screw Holes | 2, 3, 4, 5, 6, 7, 8, 10, 12, 14, and 16 holes | Various, 7 - 24 holes | 3, 4, 5, 6, 7, 8, 9, 10, and 12 holes | Various, 2-12 holes | 12 or 13 holes | Various |
| Plate Thickness | 2, 3, and 4 hole plates: 2.4 mm5-16 hole plates: 2.2. mm | Various thicknesses,1.6 mm - 30.5 mm | 1 mm | Not provided in 510(k) Summary | 1.4 mm to 2.0 mm | 1.6 mm to 2.5 mm |
| Plate Lengths | Various lengths,32 mm - 200 mm | Various lengths,50 mm - 260 mm | 3-10 hole plates: 33 mm - 117 mm12 hole plates: 141 mm | 28 mm - 148 mm | Various overall dimensions | Various lengths,25 mm to 92 mm |
| Plate Width | 10.2 mm in the widest part | Various widths | 9.8 mm | Not provided in 510(k) Summary | Various overall dimensions | Various widths,12 mm to 29 mm |
| Sterility | Provided non-sterile and sterile | Provided non-sterile and sterile | Not provided in 510(k) Summary | Provided non-sterile and sterile | Provided non-sterile | Provided non-sterile |
| Sterilization | Non-sterile: to be sterilized by moist heatSterile: X-ray beam sterilization | Non-sterile: to be sterilized by moist heatSterile: X-ray beam sterilization | Not provided in 510(k) Summary | Non-sterile: to be sterilized by moist heat | Non-sterile: to be sterilized by moist heat |
Substantial Equivalence – Technological Characterist
§ 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.