(91 days)
No
The device description and performance studies focus on the mechanical properties and design of bone plates and screws for clavicle fixation. There is no mention of AI, ML, image processing, or any software-based analysis or decision-making.
Yes
The device is a bone plate system designed for the internal fixation of fractured clavicles, which is a therapeutic intervention aimed at treating and healing these conditions.
No
Explanation: The device, the APTUS® Clavicle System, is described as bone plates and inserts used for internal fixation of the clavicle to treat fractures, osteotomies, malunions, and non-unions. This is a therapeutic function, not a diagnostic one.
No
The device description clearly details physical bone plates made of titanium alloy, which are hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of fractures, osteotomies, malunions, and non-unions of the clavicle. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is a system of bone plates and screws for internal fixation. This is a surgical implant, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status based on such testing.
Therefore, the APTUS® Clavicle System is a surgical device for internal fixation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
APTUS® Clavicle System is indicated for treatment of fractures, osteotomies, malunions and non-unions of the clavicle.
Product codes (comma separated list FDA assigned to the subject device)
HRS
Device Description
This submission includes a total of 22 bone plates for internal fixation of the clavicle.
Superior Lateral Plates are provided in 12-hole and 14-hole designs for the left and right clavicle, with pre-bent flaps that allow for additional anteroposterior screw fixation. The Superior Lateral Plates include an oblong hole in the plate for an optional plate insert that is provided in two (2) designs: one insert design is for suture fixation of the coracoclavicular ligament, and one insert design is for placement of an additional cortical screw. The Superior Lateral Plates have a curved shape, a maximum thickness of 3.4 mm. and an overall length between approximately 78 mm and 100 mm.
Superior Lateral Shaft Plates are provided in an 11-hole design for the left and right clavicle. The Superior Lateral Shaft Plates are designed for stable fixation of fractures on the lateral third of the midshaft without compromising the capsule and the acromioclavicular (AC) joint. The Superior Lateral Shaft Plates have a curved shape, a maximum thickness of 3.4 mm, and an overall length of approximately 94 mm.
Superior Midshaft Plates are provided in 6-hole, 10-hole, and 12-hole designs for the left and right clavicle. The 8-hole plates are provided with three (3) different S-shaped curvatures. The plates have a maximum thickness of 3.4 mm and an overall length between approximately 84 mm and approximately 141 mm.
Anterior Midshaft Plates are provided in 6-hole, 8-hole, and 10-hole designs for midshaft fractures of the clavicle. The Anterior Midshaft plates are designed for use on either the left or right clavicle. The plates have a maximum thickness of 3.4 mm, and an overall length between approximately 8 mm and approximately 118 mm.
The Anterior Lateral Plate is provided in a 6-hole design for lateral fractures of the left or right clavicle. The plate has a maximum thickness of 3.4 mm, and an overall length of approximately 80 mm.
All of the subject device plates and the plate inserts for the Superior Lateral Plates are manufactured from titanium alloy conforming to ASTM F136.
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 compatible screws are 2.8 mm in diameter and were previously cleared in K091479 and K103332. The subject device plates also are compatible with 1.6 mm diameter Medartis APTUS® K-Wires previously cleared in K092038.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Clavicle, upper extremity
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 testing and sterilization referenced from K191848 and K181425; engineering analysis; static tensile testing of suture-suture insert-plate constructs and stating of suture-simulated clavicle bone constructs; and comparative dynamic mechanical testing in a simulated fracture model. Clinical data were not provided in this submission.
Key Results: Mechanical performance of the subject device included comparative dynamic (fatigue) testing of worst-case, simulated clavicle fracture constructs. For three groups of the subject device plates (Superior Lateral Plates, Superior Midshaft and Lateral Shaft Plates, and Anterior Plates), the mechanically weakest subject device plate was selected for mechanical testing, and compared to a predicate device plate tested under the same conditions. Predicate device plates were selected based on the intended use (placement location on the clavicle for fixation of the specific fracture), the use of locking screws (as with the subject device plates), similar material, and similar dimensions. Based on the resting, the performance of the subject device was judged to be substantially equivalent to the primary predicate K111540 and the other predicate devices K073186 and K101536. Static testing demonstrated that the tensile strength of suture suture insert-plate constructs was significantly greater than the tensile strength of suture-simulated clavicle bone constructs.
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.
K111540, K073186, K101536, K112111
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
January 24, 2020
Image /page/0/Picture/1 description: The image shows 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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: K192984
Trade/Device Name: APTUS Clavicle System 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: October 25, 2019 Received: October 25, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
APTUS® Clavicle System
Indications for Use (Describe)
APTUS® Clavicle System is indicated for treatment of fractures, osteotomies, malunions and non-unions of the clavicle.
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
K192984
Medartis AG
APTUS® Clavicle System
January 8, 2020
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: | +1 858-792-1236 | ||
| Email: | kthomas@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | APTUS® Clavicle System |
|---|---|
| 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) |
PREDICATE DEVICE INFORMATION
Primary Predicate Device K111540, Synthes 3.5 mm LCP Clavicle Plate System, Synthes (USA)
Other Predicate Devices K073186, Synthes 3.5 mm LCP Clavicle Plate System, Synthes (USA) K101536, 2.7/3.5 mm VA-LCP Anterior Clavicle Plate System, Synthes (USA) K112111, Acu-Sinch Repair System, Acumed LLC
4
510(k) Summary Page 2 of 7
Reference Devices K110176, AxSOS® Locked Plating System Line Extension of 4 mm Locking Inserts, Howmedica Osteonics Corp. K191848, APTUS® Wrist 2.5 System, Medartis AG K181425, APTUS® Proximal Humerus System, Medartis AG
INDICATIONS FOR USE STATEMENT
APTUS® Clavicle System is indicated for treatment of fractures, osteotomies, malunions and non-unions of the clavicle.
SUBJECT DEVICE DESCRIPTION
This submission includes a total of 22 bone plates for internal fixation of the clavicle.
Superior Lateral Plates are provided in 12-hole and 14-hole designs for the left and right clavicle, with pre-bent flaps that allow for additional anteroposterior screw fixation. The Superior Lateral Plates include an oblong hole in the plate for an optional plate insert that is provided in two (2) designs: one insert design is for suture fixation of the coracoclavicular ligament, and one insert design is for placement of an additional cortical screw. The Superior Lateral Plates have a curved shape, a maximum thickness of 3.4 mm. and an overall length between approximately 78 mm and 100 mm.
Superior Lateral Shaft Plates are provided in an 11-hole design for the left and right clavicle. The Superior Lateral Shaft Plates are designed for stable fixation of fractures on the lateral third of the midshaft without compromising the capsule and the acromioclavicular (AC) joint. The Superior Lateral Shaft Plates have a curved shape, a maximum thickness of 3.4 mm, and an overall length of approximately 94 mm.
Superior Midshaft Plates are provided in 6-hole, 10-hole, and 12-hole designs for the left and right clavicle. The 8-hole plates are provided with three (3) different S-shaped curvatures. The plates have a maximum thickness of 3.4 mm and an overall length between approximately 84 mm and approximately 141 mm.
Anterior Midshaft Plates are provided in 6-hole, 8-hole, and 10-hole designs for midshaft fractures of the clavicle. The Anterior Midshaft plates are designed for use on either the left or right clavicle. The plates have a maximum thickness of 3.4 mm, and an overall length between approximately 8 mm and approximately 118 mm.
The Anterior Lateral Plate is provided in a 6-hole design for lateral fractures of the left or right clavicle. The plate has a maximum thickness of 3.4 mm, and an overall length of approximately 80 mm.
All of the subject device plates and the plate inserts for the Superior Lateral Plates are manufactured from titanium alloy conforming to ASTM F136.
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 compatible screws are 2.8 mm in diameter and were previously cleared in K091479 and K103332. The subject device plates also are compatible with 1.6 mm diameter Medartis APTUS® K-Wires previously cleared in K092038.
5
PERFORMANCE DATA
Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: biocompatibility testing and sterilization referenced from K191848 and K181425; engineering analysis; static tensile testing of suture-suture insert-plate constructs and stating of suture-simulated clavicle bone constructs; and comparative dynamic mechanical testing in a simulated fracture model. 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, the other predicate devices, and the reference 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, the other predicate devices, and the reference devices.
The subject device, the primary predicate device, the other predicate devices, and the reference devices have the same intended use for internal fixation of the bones of the upper extremity and lower extremity (K110176). The Indications for Use Statement for the subject device is very similar to the Indications for Use Statement for K073186; the minor differences in language do not impact substantial equivalence.
The differences among the Indications for Use Statements for the subject device, the primary predicate (K111540), the other predicate devices (K101536, K112111), and the reference devices (K110176, K191848, K181425) include language regarding: use in adults and adolescents (K111540, K101536); use in specific procedures (K11211); use in fixation of the lower extremity (K110176); use in fixation of the forearm (K191848); and use in fixation of the proximal humerus (K181425). These differences do not impact substantial equivalence because all IFUS express equivalent intended use for internal fixation of the bones of the upper extremity or lower extremity, and the devices are included to support substantial equivalence as described in this section.
The plates from the subject device, the primary predicate device (K111540), the other predicate devices (K073186, K101536, K11211), and the reference devices (K110176, K191848, K181425) have the same technological characteristics, have similar design characteristics, screw holes to accommodate locking and non-locking screws, and use the same operating principles for bone fixation.
The plates from the subject device, the primary predicate device (K111540), and the other predicate devices (K073186, K101536, K11211) include similar anatomic designs for superior or anterior surgical placement on the clavicle. The plates from the subject device, the primary predicate (K111540), and the other predicate devices K073186 and K101536 encompass a similar range of physical features and dimensions (number of screw holes, overall length, and thickness).
The other predicate device K112111 is for support of substantial equivalence of the subject device Insert for Suture Fixation. The Acu-Sinch insert (K112111) and the subject device Insert for Suture Fixation have similar design features and are made of the same or similar materials (titanium alloy or unalloyed titanium). The differences between the subject device Fixation and the Acu-Sinch insert include the overall shape (rectangular versus oval) and the specific compatible plate designs.
The reference device K110176 is for support of substantial equivalence of the subject device Insert for Cortical Screw Fixation. The 4 mm Locking Insert (K110176) and the subject device Insert for Cortical Screw Fixation have similar design features. The differences between the devices include the specific compatible plate designs, the use with locking (K110176) or non-locking cortical screws (subject device),
6
and the materials used for manufacturing (K110176 is manufactured from stainless steel, versus the subject device is manufactured from titanium alloy).
The plates and plate inserts from the subject device and the reference device K191848 are manufactured from the identical titanium alloy material conforming to ASTM F136. All of the 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, including plates in K191848 and instruments and trays in K181425. Therefore, the subject device is substantially equivalent to the reference devices K191848 and K181425 regarding biocompatibility.
The subject device components and the Medartis device components cleared in K181425 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, the primary predicate device, the other predicate devices, and the reference devices do not impact safety or effectiveness.
The differences among the plates from the subject device, the primary predicate device, the other predicate devices, and the reference devices are variations in 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 primary predicate K111540 and the other predicate devices K073186 and K 101536 are manufactured from a different titanium alloy (Ti-6Al-7Nb) material compared to the subject device material (Ti-6Al-4V). Similarly, the 4 mm Locking Insert from K110176 is manufactured from a different material (stainless steel). These slight differences among the subject device and the predicate and reference devices do not impact safety or effectiveness.
Mechanical performance of the subject device included comparative dynamic (fatigue) testing of worstcase, simulated clavicle fracture constructs. For three groups of the subject device plates (Superior Lateral Plates, Superior Midshaft and Lateral Shaft Plates, and Anterior Plates), the mechanically weakest subject device plate was selected for mechanical testing, and compared to a predicate device plate tested under the same conditions. Predicate device plates were selected based on the intended use (placement location on the clavicle for fixation of the specific fracture), the use of locking screws (as with the subject device plates), similar material, and similar dimensions. Based on the resting, the performance of the subject device was judged to be substantially equivalent to the primary predicate K111540 and the other predicate devices K073186 and K101536. Static testing demonstrated that the tensile strength of suture suture insert-plate constructs was significantly greater than the tensile strength of suture-simulated clavicle bone constructs.
CONCLUSION
The subject device, the primary predicate device, and the reference devices have the same intended use, have similar technological characteristics, and encompass a similar range of physical dimensions appropriate to the anatomy. The data included in this submission demonstrate substantial equivalence to the primary predicate device, the other predicate devices, and the reference devices listed above.
7
Substantial Equivalence – Indications for Use Statements
| Indications for Use Statement | |
|---|---|
| Subject Device | |
| K192984 | |
| APTUS® Clavicle System | |
| Medartis AG | APTUS® Clavicle System is indicated for treatment of fractures, osteotomies, malunions and non-unions of the clavicle. |
| Primary Predicate Device | |
| K111540 | |
| Synthes 3.5 mm LCP Clavicle Plate System | |
| Synthes (USA) | The Synthes 3.5mm LCP Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults |
| and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate. | |
| Other Predicate Devices | |
| K073186 | |
| Synthes 3.5 mm LCP Clavicle Plate System | |
| Synthes (USA) | Synthes 3.5 mm LCP Clavicle Plate System is intended for fixation of fractures, malunions, non-unions. and osteotomies of the clavicle. |
| K101536 | |
| 2.7/3.5 mm VA-LCP Anterior Clavicle Plate System | |
| Synthes (USA) | The Synthes 2.7 mm/ 3.5 mm VA-LCP Anterior Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle |
| and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates. | |
| K112111 | |
| Acu-Sinch Repair System | |
| Acumed LLC | The Acu-Sinch Repair System is intended to be used in conjunction with a clavicle plate of the Congruent Bone Plate System to provide fixation during. |
| The Acu-Sinch Repair System also may be used as a stand-alone system for treatment of acromioclavicular and/or coracoclavicular ligament disruption. | |
| The Acumed Suture Anchor is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures: | |
| • Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift/Release | |
| • Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair | |
| • Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Reconstruction | |
| • Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction | |
| • Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction | |
| Acumed's Locking Clavicle Plating System is designed to provide fixation during fractures, fusions, or osteotomies of the clavicle. | |
| Reference Devices | |
| K110176 | |
| AxSOS® Locked Plating System Line Extension of | |
| 4 mm Locking Inserts | |
| Howmedica Osteonics Corp. | The AxSOS Locked Plating System in the Stryker Locked Plating System are intended for use in long bone fracture fixation. The AxSOS Locked Plating |
| fractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia, and the distal femur. | |
| K191848 | |
| APTUS® Wrist 2.5 System | |
| Medartis AG | APTUS® Wrist Spanning Plates 2.5 are intended for use in forearm fractures. |
| K181425 | |
| APTUS® Proximal Humerus System | |
| Medartis AG | APTUS® Proximal Humerus System is indicated for fractures, osteotomies and non-unions of the proximal humerus. |
| and in both adolescents (12-18 years) |
|---|
| e system. |
| the clavicle in adults, |
| h plates will not be crossed by the plate system. |
| the healing of clavicle fractures. |
| es: |
| sular Shift or Capsulolabral Reconstruction |
| Ligament Repair |
| Oblique Ligament Repair, and Iliotibial Band Tenodesis |
| ng System is indicated for fixation of long bone fractures including |
8
Substantial Equivalence – Technological Characteristics
| Subject Device | Primary Predicate/Other Predicate Devices | Other Predicate Device | Reference Device | ||
|---|---|---|---|---|---|
| K193984 | |||||
| APTUS® Clavicle System | K111540 (Primary Predicate Device) | ||||
| Synthes 3.5 mm LCP Clavicle Plate System | K112111 | ||||
| Acu-Sinch Repair System | K110176 | ||||
| AxSOS® Locked Plating System Line Extension of | |||||
| 4 mm Locking Inserts | APT | ||||
| Comparison | K073186 (Other Predicate Device) | ||||
| Synthes 3.5 mm LCP Clavicle Plate System | |||||
| K101536 (Other Predicate Device) | |||||
| 2.7/3.5 mm VA-LCP Anterior Clavicle Plate | |||||
| System | |||||
| Medartis AG | Synthes USA | Acumed LLC | Howmedica Osteonics Corp. | ||
| Product Code | HRS | HRS (K111540; K073186) | |||
| HRS, HWC (K101536) | HTN, HRS, HWC, MBI | HRS, HWC | HRS, HWC | ||
| 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 and lower extremities | Internal fixation of the |
| Reason for | |||||
| Predicate/Reference | |||||
| Device | Not applicable | Plate designs; | |||
| Plates used in comparison mechanical testing | Acu-Sinch plate insert device design | Locking plate insert device design | Reference device fo | ||
| Ti-6Al-4V alloy, A | |||||
| Plates | Plates described below are compatible with the | ||||
| Acu-Sinch insert device | Plates described below are compatible with the | ||||
| locking plate insert device | |||||
| Plate Designs | Anatomic plate designs | ||||
| Multiple designs and sizes | |||||
| Designs for superior and anterior surgical | |||||
| placement | |||||
| Screw holes accommodate locking and non-locking | |||||
| (cortex) screws | Anatomic plate designs | ||||
| Multiple sizes | |||||
| Multiple designs | |||||
| Designs for superior and anterior surgical | |||||
| placement | |||||
| Screw holes accommodate locking and non-locking | |||||
| (cortex) screws | Anatomic plate designs | ||||
| Multiple sizes | |||||
| Multiple designs | |||||
| Designs for superior and anterior surgical | |||||
| placement | |||||
| Screw holes accommodate locking and non-locking | |||||
| (cortex) screws | |||||
| Plate designs accommodate Acu-Sinch insert | Anatomic plate designs | ||||
| Multiple sizes | |||||
| Multiple designs | |||||
| Designs for superior and anterior surgical | |||||
| placement | |||||
| Screw holes accommodate locking and non-locking | |||||
| (cortex) screws | |||||
| Plate designs accommodate locking insert | Straight and anaton | ||||
| Two sizes (lengths) | |||||
| Designs for dorsal s | |||||
| Screw holes accom | |||||
| locking screws | |||||
| Superior Midshaft Plates | |||||
| Superior Lateral Shaft Plates | |||||
| Superior Lateral Plates | |||||
| Anterior Midshaft Plates | |||||
| Anterior Lateral Plates | LCP Superior Clavicle Plates | ||||
| LCP Superior Anterior Clavicle Plates | |||||
| VA-LCP Anterior Clavicle Plates | Superior Midshaft Plates (low profile, narrow | ||||
| profile) | |||||
| Anterior Medial Plates | |||||
| Anterior Lateral Plates | |||||
| Superior Distal Plates | Proximal Humeral Plates | ||||
| Proximal Lateral Tibial Plates | |||||
| Distal Lateral Femoral Plates | |||||
| Distal Medial Tibial Plates | |||||
| Distal Anterolateral Tibial Plates | |||||
| Plate Features and | |||||
| Overall Dimensions | |||||
| (approximate) | Superior Midshaft Clavicle Plate | ||||
| Screw holes: 6, 8, 10, 12 | |||||
| Plate length: 83-141 mm | |||||
| Plate thickness 3.4 mm | LCP Superior Clavicle Plate 3.5 | ||||
| Screw holes: 6, 7, 8 | |||||
| Plate length: 94-123 mm | |||||
| Plate thickness: not available | Locking Clavicle Plate | ||||
| Screw holes: 6, 8, 10 | |||||
| Plate length: not available | |||||
| Plate thickness: not available | Not applicable (plates are not for the clavicle) | Not applicable (pla | |||
| Superior Lateral Shaft Clavicle Plate | |||||
| Screw holes: 11 | |||||
| Plate length: 94 mm | |||||
| Plate thickness 3.4 mm, tapering laterally | LCP Superior Clavicle Plate 2.7/3.5 with Lateral | ||||
| Extension | |||||
| Screw holes: 6, 7, 8 | |||||
| Plate length: 110-136 mm | |||||
| Plate thickness: not available | Locking Clavicle J-Plate | ||||
| Screw holes: 8, 9 | |||||
| Plate length: not available | |||||
| Plate thickness: not available | |||||
| Superior Lateral Clavicle Plate | |||||
| Screw holes: 12, 14 | |||||
| Plate length: 78-100 mm | |||||
| Plate thickness 3.4 mm, tapering laterally | LCP Anterior Clavicle Plate 3.5 | ||||
| Screw holes: 6, 7, 8 | |||||
| Plate length: 79–102 mm | |||||
| Plate thickness: not available | Low-profile Superior Midshaft Clavicle Plate | ||||
| Screw holes: 8, 10 | |||||
| Plate length: not available | |||||
| Plate thickness: not available | |||||
| Anterior Midshaft Clavicle Plate | |||||
| Screw holes: 6, 8, 10 | |||||
| Plate length: 82-118 mm | |||||
| Plate thickness 3.4 mm | VA-LCP Anterior Clavicle Plate 2.7/3.5 | ||||
| Screw holes: 7, 9, 10, 11, 12 | |||||
| Plate length: 77–124 mm | |||||
| Plate thickness 3.4 mm | Narrow-profile Superior Midshaft Clavicle Plate | ||||
| Screw holes: 6, 8 | |||||
| Plate length: not available | |||||
| Plate thickness: not available | |||||
| Anterior Lateral Clavicle Plate | |||||
| Screw holes: 6 | |||||
| Plate length: 80 mm | |||||
| Plate thickness 3.4 mm | LCP Superior Anterior Clavicle Plate | ||||
| Screw holes: 3, 4, 5 | |||||
| Plate length: 94-120 mm | |||||
| Plate thickness 3.4 mm | Superior Distal Clavicle Plate | ||||
| Screw holes: 8, 9, 12, 13, 16 | |||||
| Plate length: not available | |||||
| Plate thickness: not available | |||||
| LCP Superior Anterior Clavicle Plate 2.7/3.5 with | |||||
| Lateral Extension | |||||
| Screw holes: 3, 4, 5, 6, 7, 8 | |||||
| Plate length: 69-135 mm | |||||
| Plate thickness 3.4 mm | Anterior Medial Clavicle Plate | ||||
| Screw holes: 6, 8, 10 | |||||
| Plate length: not available | |||||
| Plate thickness: not available | |||||
| Subject Device | Primary Predicate/Other Predicate Devices | Other Predicate Device | Reference Device | ||
| Comparison | K193984 | ||||
| APTUS® Clavicle System | K111540 (Primary Predicate Device) | ||||
| Synthes 3.5 mm LCP Clavicle Plate System | |||||
| K073186 (Other Predicate Device) | |||||
| Synthes 3.5 mm LCP Clavicle Plate System | |||||
| K101536 (Other Predicate Device) | |||||
| 2.7/3.5 mm VA-LCP Anterior Clavicle Plate | |||||
| System | K112111 | ||||
| Acu-Sinch Repair System | K110176 | ||||
| AxSOS® Locked Plating System Line Extension of | |||||
| 4 mm Locking Inserts | |||||
| Medartis AG | Synthes USA | Acumed LLC | Howmedica Osteonics Corp. | ||
| Anterior Lateral Clavicle Plate | |||||
| Screw holes: 6, 8 | |||||
| Plate length: not available | |||||
| Plate thickness: not available | |||||
| Plate Materials | Ti-6Al-4V alloy, ASTM F136 | Ti-6Al-7Nb alloy | Unalloyed titanium, ASTM F67 | ||
| Ti-6Al-4V alloy, ASTM F136 | Stainless steel, ASTM F138, ASTM F139 | ||||
| Plate Inserts | |||||
| Insert Designs | Insert for Suture Fixation Clavicle | ||||
| Thickness: 4 mm | |||||
| Length: 7.5 mm | Acu-Sinch insert device | ||||
| Suture retainer (suture button) | |||||
| Dimensional information not available | |||||
| Insert for Cortical Screw Fixation Clavicle | |||||
| Thickness: 4 mm | |||||
| Length: 8.5 mm | 4 mm Locking Insert | ||||
| Dimensional information not available | |||||
| Insert Materials | Ti-6Al-4V alloy, ASTM F136 | Unalloyed titanium, ASTM F67 | |||
| Ti-6Al-4V alloy, ASTM F136 | Stainless steel, ASTM F138, ASTM F139 | ||||
| Compatible Screws | |||||
| Screw Design | Previously cleared Medartis APTUS Screws | ||||
| (K091479, 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 | Compatible screws: | ||||
| Locking screws | |||||
| Cortical screws (non-locking) | Compatible screws: | ||||
| Locking screws | |||||
| Cortical screws (non-locking) | |||||
| Cancellous screws | Compatible screw information from catalog, | ||||
| not in K110167 | |||||
| Locking screws | |||||
| Cortical screws | |||||
| Cancellous screws | |||||
| Screw Diameters | Previously cleared: | ||||
| 2.8 mm (locking and non-locking) | Locking screws: 2.7 mm, 3.5 mm | ||||
| Cortical screws: 2.4 mm, 3.5 mm | Locking screws: 2.3, 2.7, 3.5 mm | ||||
| Cortical screws: 2.3, 2.7, 3.0, 3.5 mm | |||||
| Cancellous screws: 4.0 mm | Compatible screw information from catalog, | ||||
| not in K110167 | |||||
| Locking screws: 4.0 mm | |||||
| Cortical screws: 3.5 mm | |||||
| Cancellous screws: 4.0 mm | |||||
| Screw Lengths | Previously cleared: | ||||
| 8 mm to 36 mm (non-locking) | |||||
| 8 mm to 36 mm (locking) | Locking screws | ||||
| 14-32 mm (2.7 mm diameter) | |||||
| 12-30 mm (3.5 mm diameter) | |||||
| Cortical screws | |||||
| 14-30 mm (2.4 mm diameter) | |||||
| 12-30 mm (3.5 mm diameter) | Locking screws | ||||
| 8-26 mm (2.3 diameter);8-65 mm (2.7 diameter) | |||||
| 6-65 mm (3.5 mm diameter) | |||||
| Cortical screw | |||||
| 8-26 mm (2.3 diameter);8-65 mm (2.7 diameter) | |||||
| 8-26 mm (3.0 diameter);6-65 mm(3.5 mm diameter) | |||||
| Cancellous screws 12-60 mm (4.0 mm diameter) | Compatible screw information from catalog, | ||||
| not in K110167 | |||||
| Locking screws: 14-95 mm | |||||
| Cortical screws: 14-95 mm | |||||
| Cancellous screws:14-95 mm | |||||
| Screw Materials | Previously cleared: | ||||
| Ti-6Al-4V alloy, ASTM F136 | Compatible screws: | ||||
| Ti-6Al-7Nb alloy | Compatible screws: | ||||
| Unalloyed titanium, ASTM F67 | |||||
| Ti-6Al-4V alloy, ASTM F136 | Compatible screws: | ||||
| Stainless steel, ASTM F138, ASTM F139 | |||||
| How Provided | |||||
| Sterility | Provided non-sterile | Provided non-sterile | Provided non-sterile | 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 | End user to sterilize by moist heat | |
| Usage | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use | Single-patient, single-use |
| Reference Device | Reference Device |
|---|---|
| K191848 | |
| APTUS ® Wrist 2.5 System | K181425 |
| APTUS ® Proximal Humerus System | |
| Medartis AG | Medartis AG |
| HRS, HTY, HWC | |
| of the upper extremity | Internal fixation of the upper extremity |
| for plate and plate insert material, | |
| ASTM F136 | Reference device for device-specific template material (Unalloyed titanium, ASTM F67), and device-specific instruments and trays materials (stainless steel; PEEK; PPSU) |
| Anatomic plate designs (wrist) | |
| s) | |
| l surgical placement | |
| mmodate non-locking (cortex) and | Anatomic plate designs (proximal humerus) |
| Multiple sizes; | |
| 3, 5, and 7 shaft screw hole plates; | |
| Specific plates for right and left proximal humerus; | |
| Screw holes accommodate conventional and locking screws; | |
| Locking blades | |
| lates are not for the clavicle) | Not applicable (plates are not for the clavicle) |
9
Substantial Equivalence – Technological Characteristics
| Reference Device | Reference Device |
|---|---|
| K191848 | |
| APTUS® Wrist 2.5 System | K181425 |
| APTUS® Proximal Humerus System | |
| Medartis AG | Medartis AG |
| ASTM F136 | Unalloyed titanium, ASTM F67 |
| Medartis APTUS Screws | |
| (4.332): | |
| Locking screws: cortical thread form, double-lead | |
| thread, self-tapping, fully threaded | |
| Non-locking screws: cortical thread form, single- | |
| thread, self-tapping, fully threaded | Locking screws: cortical thread form, double |
| thread, self-tapping, fully threaded | |
| Non-locking screws: cortical thread form, single | |
| thread, self-tapping, fully threaded | |
| Diameter: | 3.5 mm |
| (locking and non-locking) | |
| Length: | |
| (locking and non-locking) | Locking and non-locking: |
| 16 mm to 60 mm | |
| Material: | |
| ASTM F136 | Ti-6Al-4V alloy, ASTM F136 |
| Provided non-sterile | |
| Sterilization | End user to sterilize by moist heat |
| Single-use | Single-patient, single-use |