(70 days)
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 arthrodoses t
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.
The APTUS® Titanium Fixation System consists of implant plates and implant screws and is used for internal fixation of small bones.
APTUS Plates
Implant Modules are provided in sizes Hand 1.2, Hand 1.5, Hand 2.0, Hand 2.3 for miplant Modules are pro rised in oristius reconstruction plate system is used for fixation valious iniger segmonts. The distal for corrective osteotomies of the distal radius with of fractures or the under laccess. Variations of plate shapes include H frame, straight, T and L shaped.
APTUS Screws
Locking screws for the Radius and Hand 2.0 Lock product lines, designated TriLock™, utilize a spherical three point wedge locking design and are used with locking plates. Conventional bone screws have a double thread design and precisely cut sharp thread profile, tapering core diameter and atraumatic tip. The shorter screws have a small pitch in order to maintain optimal purchase in the bone, while the longer screws have a larger pitch in order to minimize the number of revolutions.
This 510(k) summary for the APTUS® Titanium Fixation System does not contain information about acceptance criteria, device performance testing, or clinical studies of the nature you've requested (e.g., sample sizes for test sets, expert ground truth, MRMC studies, standalone performance).
The document is a premarket notification (510(k)) submission to the FDA, which typically focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a full clinical trial or performance validation of the type you've outlined.
Here's how the provided information relates to your request:
1. A table of acceptance criteria and the reported device performance:
- Not provided. This document highlights the "intended use" and "device description" but does not specify quantitative acceptance criteria for performance (e.g., strength, biocompatibility thresholds) or report specific performance metrics against such criteria. The basis for clearance is substantial equivalence to predicate devices, implying similar performance characteristics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. No performance test set or associated data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not provided. This type of information is typically for diagnostic or AI-driven devices where ground truth relies on expert interpretations. This document is for a medical implant (fixation system).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. MRMC studies are relevant for diagnostic devices involving human interpretation, often with AI assistance. This device is a bone fixation system, not a diagnostic tool with an AI component.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device does not have an algorithm component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided in the context of device performance. For a fixation system, "ground truth" often refers to clinical success (e.g., fracture healing, absence of complications) which would be assessed in clinical studies, but such studies are not detailed here for this 510(k). The focus is on material properties and mechanical design mirroring predicates.
8. The sample size for the training set:
- Not applicable/Not provided. There is no "training set" as this device does not involve a machine learning algorithm.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
Summary of available information relevant to regulatory submission principles:
The 510(k) summary describes the APTUS® Titanium Fixation System as implants (plates and screws) for internal fixation of small bones in hand and forearm fractures, osteotomies, and arthrodeses.
The primary "proof" that the device meets regulatory requirements for marketing is its substantial equivalence to already legally marketed predicate devices. The document lists the following predicate devices:
- Profyle™ Titanium Hand and Small Fragment System (K961497) from Howmedica (Stryker)
- Stryker® Leibinger Universal Distal Radius System (K040022) from Stryker Leibinger
- Distal Radius Fracture Repair System (K002775, K023007, K030198) from Hand Innovations
- Fragment Plate System (K041081) from Hand Innovations
The equivalence is asserted "in indications and design principles." This implies that the materials, mechanical properties (even if not explicitly quantified in this summary), sterilization, and general design features are considered similar enough to the predicate devices that no new safety or effectiveness concerns are raised, negating the need for extensive new clinical studies for this specific clearance.
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510(k) Summary
AUG 2 3 2005
Image /page/0/Picture/2 description: The image shows the text "K051567" in a handwritten-like font, followed by the text "APTUS® Titanium Fixation System" in a smaller, sans-serif font. The text appears to be part of a product label or document. The "APTUS®" portion includes a registered trademark symbol.
510(k) Summary APTUS® Titanium Fixation System, Medartis, Inc.
ADMINISTRATIVE INFORMATION
| Manufacturer Name: | Medartis, Inc.127 W Street Road, Suite 203Kennett Square, PA 19348 |
|---|---|
| -------------------- | ---------------------------------------------------------------------------- |
Telephone (610) 961-6101 FAX (610) 961-6108
Kate Gehret
Official Contact:
Representative/Consultant:
Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone (858) 792-1235 FAX (858) 792-1236
APTUS® Titanium Fixation System
DEVICE NAME
Common Name:
Classification Name:
· Single/multiple component metallic bone fixation appliances and accessories
Trade/Proprietary Name:
Plate, Fixation, Bone
DEVICE CLASSIFICATION
FDA has classified bone fixation plates as Class II devices (21 CFR 888.3030). The product code for bonc fixation plates is HRS. This device classification is reviewed by the Orthopedic Devices Branch.
INTENDED USE
The APTUS® Titanium Fixation System is intended for use in hand and forearm fractures, osteotomies and arthrodeses.
Page I of 2
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510(k) Summary
DEVICE DESCRIPTION
The APTUS® Titanium Fixation System consists of implant plates and implant screws and is used for internal fixation of small bones.
APTUS Plates
Implant Modules are provided in sizes Hand 1.2, Hand 1.5, Hand 2.0, Hand 2.3 for miplant Modules are pro rised in oristius reconstruction plate system is used for fixation valious iniger segmonts. The distal for corrective osteotomies of the distal radius with of fractures or the under laccess. Variations of plate shapes include H frame, straight, T and L shaped.
APTUS Screws
Locking screws for the Radius and Hand 2.0 Lock product lines, designated TriLock™, utilize a spherical three point wedge locking design and are used with locking plates. Conventional bone screws have a double thread design and precisely cut sharp thread profile, tapering core diameter and atraumatic tip. The shorter screws have a small pitch in order to maintain optimal purchase in the bone, while the longer screws have a larger pitch in order to minimize the number of revolutions.
EQUIVALENCE TO MARKETED PRODUCT
The APTUS® Titanium Fixation System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices: Profyle™ Titanium Hand and Small Fragment System (K961497) from Howmedica (Stryker); Stryker® Leibinger Universal Distal Radius System (K040022) from Stryker Leibinger; and Distal Radius Fracture Repair System (K002775, K023007, K030198) and Fragment Plate System (K041081) from Hand Innovations.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The symbol is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged around the border of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2005
Medartis, Inc. c/o Mr. Floyd G. Larson President PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130
Re: K051567
Trade/Device Name: APTUS® Titanium System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: June 13, 2005 Received: June 14, 2005
Dear Mr. Larson:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Floyd G. Larson
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: APTUS® Titanium Fixation System
Indications for Use:
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 arthrodoses t
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.
| Prescription Use X(Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use ______(21 CFR 801-Subpart C) | |
|---|---|---|---|
| -- | --------------------------------------------------- | -------- | ------------------------------------------------------- |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
| Page 1 of 1 | Division of General, Restorative, and Neurological Devices |
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iv
| 510(k) Number | K051567 |
|---|---|
| --------------- | --------- |
§ 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.