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.

AI/ML Overview

The provided document is a 510(k) summary for the Medartis APTUS Clavicle System. It details the device's substantial equivalence to predicate devices, focusing on design, intended use, and technological characteristics. However, it explicitly states that clinical data were not provided in this submission. The performance data consists solely of non-clinical testing.

Therefore, the document does not contain information about acceptance criteria for device performance based on clinical outcomes or studies that typically involve human subjects or expert assessment.

Here's a breakdown of what can be extracted or inferred from the provided text, and what is explicitly stated as not available:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance (Summary from Non-Clinical Testing)
Biocompatibility	Conformance to established standards	Referenced from K191848 and K181425 (previously cleared Medartis devices using identical materials and processes).
Sterilization	Conformance to established standards	Referenced from K191848 and K181425 (previously cleared Medartis devices using identical materials and processes).
Engineering Analysis	Not explicitly detailed	Performed to assess device design and characteristics.
Static Tensile Strength	Suture-suture insert-plate constructs significantly greater than suture-simulated clavicle bone constructs	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.
Dynamic Mechanical Testing (Fatigue)	Performance of subject device comparable to predicate device in a simulated fracture model	For three groups of the subject device plates, the mechanically weakest plate was selected and compared to a predicate device plate under the same conditions. Performance was judged to be substantially equivalent to predicates K111540, K073186, and K101536.

2. Sample size used for the test set and the data provenance:

Sample size: Not applicable for clinical test sets as "Clinical data were not provided in this submission." For non-clinical mechanical testing, the mechanically weakest subject device plate was selected for three groups of the subject device plates. Specific numbers of plates tested are not provided.
Data provenance: Non-clinical (laboratory testing). No country of origin for non-clinical test data is specified. The study is not retrospective or prospective in a clinical sense as it is entirely non-clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No clinical ground truth was established by medical experts for this submission as "Clinical data were not provided in this submission." The ground truth for non-clinical testing is based on engineering principles and material science.

4. Adjudication method for the test set:

Not applicable. No clinical test set or adjudication by experts was performed.

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:

No. This is a medical device (bone fixation system), not an AI diagnostic or assistive device. Therefore, no MRMC study or AI-related comparative effectiveness was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is a medical device (bone fixation system), not an algorithm or software. No standalone algorithm performance was assessed.

7. The type of ground truth used:

Non-clinical: Engineering measurements and material property standards (e.g., ASTM F136 for titanium alloy, ASTM F67 for unalloyed titanium, ASTM F138/F139 for stainless steel). The "ground truth" for substantial equivalence was based on comparisons of design, materials, intended use, and mechanical performance to predicate devices already on the market.

8. The sample size for the training set:

Not applicable. This is a traditional medical device submission, not an AI/machine learning device that would typically have a "training set."

9. How the ground truth for the training set was established:

Not applicable. No training set or associated ground truth was established as this is not an AI/machine learning device.

Summary

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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

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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

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Indications for Use

510(k) Number (if known)

K192984

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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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 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)

flarson@paxmed.com

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

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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.

All of the subject device plates and the plate inserts for the Superior Lateral Plates are manufactured from titanium alloy conforming to ASTM F136.

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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),

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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.

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Substantial Equivalence – Indications for Use Statements

	Indications for Use Statement
Subject Device
K192984APTUS® Clavicle SystemMedartis AG	APTUS® Clavicle System is indicated for treatment of fractures, osteotomies, malunions and non-unions of the clavicle.
Primary Predicate Device
K111540Synthes 3.5 mm LCP Clavicle Plate SystemSynthes (USA)	The Synthes 3.5mm LCP Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adultsand 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
K073186Synthes 3.5 mm LCP Clavicle Plate SystemSynthes (USA)	Synthes 3.5 mm LCP Clavicle Plate System is intended for fixation of fractures, malunions, non-unions. and osteotomies of the clavicle.
K1015362.7/3.5 mm VA-LCP Anterior Clavicle Plate SystemSynthes (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 clavicleand 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.
K112111Acu-Sinch Repair SystemAcumed 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 ReconstructionAcumed's Locking Clavicle Plating System is designed to provide fixation during fractures, fusions, or osteotomies of the clavicle.
Reference Devices
K110176AxSOS® Locked Plating System Line Extension of4 mm Locking InsertsHowmedica 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 Platingfractures of the distal radius, the proximal humerus, the distal tibia, proximal tibia, and the distal femur.
K191848APTUS® Wrist 2.5 SystemMedartis AG	APTUS® Wrist Spanning Plates 2.5 are intended for use in forearm fractures.
K181425APTUS® Proximal Humerus SystemMedartis 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

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Substantial Equivalence – Technological Characteristics

	Subject Device	Primary Predicate/Other Predicate Devices	Other Predicate Device	Reference Device
	K193984APTUS® Clavicle System	K111540 (Primary Predicate Device)Synthes 3.5 mm LCP Clavicle Plate System	K112111Acu-Sinch Repair System	K110176AxSOS® Locked Plating System Line Extension of4 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 PlateSystem
	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 forPredicate/ReferenceDevice	Not applicable	Plate designs;Plates used in comparison mechanical testing	Acu-Sinch plate insert device design	Locking plate insert device design	Reference device foTi-6Al-4V alloy, A
Plates			Plates described below are compatible with theAcu-Sinch insert device	Plates described below are compatible with thelocking plate insert device
Plate Designs	Anatomic plate designsMultiple designs and sizesDesigns for superior and anterior surgicalplacementScrew holes accommodate locking and non-locking(cortex) screws	Anatomic plate designsMultiple sizesMultiple designsDesigns for superior and anterior surgicalplacementScrew holes accommodate locking and non-locking(cortex) screws	Anatomic plate designsMultiple sizesMultiple designsDesigns for superior and anterior surgicalplacementScrew holes accommodate locking and non-locking(cortex) screwsPlate designs accommodate Acu-Sinch insert	Anatomic plate designsMultiple sizesMultiple designsDesigns for superior and anterior surgicalplacementScrew holes accommodate locking and non-locking(cortex) screwsPlate designs accommodate locking insert	Straight and anatonTwo sizes (lengths)Designs for dorsal sScrew holes accomlocking screws
	Superior Midshaft PlatesSuperior Lateral Shaft PlatesSuperior Lateral PlatesAnterior Midshaft PlatesAnterior Lateral Plates	LCP Superior Clavicle PlatesLCP Superior Anterior Clavicle PlatesVA-LCP Anterior Clavicle Plates	Superior Midshaft Plates (low profile, narrowprofile)Anterior Medial PlatesAnterior Lateral PlatesSuperior Distal Plates	Proximal Humeral PlatesProximal Lateral Tibial PlatesDistal Lateral Femoral PlatesDistal Medial Tibial PlatesDistal Anterolateral Tibial Plates
Plate Features andOverall Dimensions(approximate)	Superior Midshaft Clavicle PlateScrew holes: 6, 8, 10, 12Plate length: 83-141 mmPlate thickness 3.4 mm	LCP Superior Clavicle Plate 3.5Screw holes: 6, 7, 8Plate length: 94-123 mmPlate thickness: not available	Locking Clavicle PlateScrew holes: 6, 8, 10Plate length: not availablePlate thickness: not available	Not applicable (plates are not for the clavicle)	Not applicable (pla
	Superior Lateral Shaft Clavicle PlateScrew holes: 11Plate length: 94 mmPlate thickness 3.4 mm, tapering laterally	LCP Superior Clavicle Plate 2.7/3.5 with LateralExtensionScrew holes: 6, 7, 8Plate length: 110-136 mmPlate thickness: not available	Locking Clavicle J-PlateScrew holes: 8, 9Plate length: not availablePlate thickness: not available
	Superior Lateral Clavicle PlateScrew holes: 12, 14Plate length: 78-100 mmPlate thickness 3.4 mm, tapering laterally	LCP Anterior Clavicle Plate 3.5Screw holes: 6, 7, 8Plate length: 79–102 mmPlate thickness: not available	Low-profile Superior Midshaft Clavicle PlateScrew holes: 8, 10Plate length: not availablePlate thickness: not available
	Anterior Midshaft Clavicle PlateScrew holes: 6, 8, 10Plate length: 82-118 mmPlate thickness 3.4 mm	VA-LCP Anterior Clavicle Plate 2.7/3.5Screw holes: 7, 9, 10, 11, 12Plate length: 77–124 mmPlate thickness 3.4 mm	Narrow-profile Superior Midshaft Clavicle PlateScrew holes: 6, 8Plate length: not availablePlate thickness: not available
	Anterior Lateral Clavicle PlateScrew holes: 6Plate length: 80 mmPlate thickness 3.4 mm	LCP Superior Anterior Clavicle PlateScrew holes: 3, 4, 5Plate length: 94-120 mmPlate thickness 3.4 mm	Superior Distal Clavicle PlateScrew holes: 8, 9, 12, 13, 16Plate length: not availablePlate thickness: not available
		LCP Superior Anterior Clavicle Plate 2.7/3.5 withLateral ExtensionScrew holes: 3, 4, 5, 6, 7, 8Plate length: 69-135 mmPlate thickness 3.4 mm	Anterior Medial Clavicle PlateScrew holes: 6, 8, 10Plate length: not availablePlate thickness: not available
	Subject Device	Primary Predicate/Other Predicate Devices	Other Predicate Device	Reference Device
Comparison	K193984APTUS® Clavicle System	K111540 (Primary Predicate Device)Synthes 3.5 mm LCP Clavicle Plate SystemK073186 (Other Predicate Device)Synthes 3.5 mm LCP Clavicle Plate SystemK101536 (Other Predicate Device)2.7/3.5 mm VA-LCP Anterior Clavicle PlateSystem	K112111Acu-Sinch Repair System	K110176AxSOS® Locked Plating System Line Extension of4 mm Locking Inserts
	Medartis AG	Synthes USA	Acumed LLC	Howmedica Osteonics Corp.
			Anterior Lateral Clavicle PlateScrew holes: 6, 8Plate length: not availablePlate thickness: not available
Plate Materials	Ti-6Al-4V alloy, ASTM F136	Ti-6Al-7Nb alloy	Unalloyed titanium, ASTM F67Ti-6Al-4V alloy, ASTM F136	Stainless steel, ASTM F138, ASTM F139
Plate Inserts
Insert Designs	Insert for Suture Fixation ClavicleThickness: 4 mmLength: 7.5 mm		Acu-Sinch insert deviceSuture retainer (suture button)Dimensional information not available
	Insert for Cortical Screw Fixation ClavicleThickness: 4 mmLength: 8.5 mm			4 mm Locking InsertDimensional information not available
Insert Materials	Ti-6Al-4V alloy, ASTM F136		Unalloyed titanium, ASTM F67Ti-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-leadthread, self-tapping, fully threadedNon-locking screws: cortical thread form, single-lead thread, self-tapping, fully threaded	Compatible screws:Locking screwsCortical screws (non-locking)	Compatible screws:Locking screwsCortical screws (non-locking)Cancellous screws	Compatible screw information from catalog,not in K110167Locking screwsCortical screwsCancellous screws
Screw Diameters	Previously cleared:2.8 mm (locking and non-locking)	Locking screws: 2.7 mm, 3.5 mmCortical screws: 2.4 mm, 3.5 mm	Locking screws: 2.3, 2.7, 3.5 mmCortical screws: 2.3, 2.7, 3.0, 3.5 mmCancellous screws: 4.0 mm	Compatible screw information from catalog,not in K110167Locking screws: 4.0 mmCortical screws: 3.5 mmCancellous screws: 4.0 mm
Screw Lengths	Previously cleared:8 mm to 36 mm (non-locking)8 mm to 36 mm (locking)	Locking screws14-32 mm (2.7 mm diameter)12-30 mm (3.5 mm diameter)Cortical screws14-30 mm (2.4 mm diameter)12-30 mm (3.5 mm diameter)	Locking screws8-26 mm (2.3 diameter);8-65 mm (2.7 diameter)6-65 mm (3.5 mm diameter)Cortical screw8-26 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 K110167Locking screws: 14-95 mmCortical screws: 14-95 mmCancellous 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 F67Ti-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
K191848APTUS ® Wrist 2.5 System	K181425APTUS ® 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 placementmmodate 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
K191848APTUS® Wrist 2.5 System	K181425APTUS® Proximal Humerus System
Medartis AG	Medartis AG
ASTM F136	Unalloyed titanium, ASTM F67



Medartis APTUS Screws(4.332):Locking screws: cortical thread form, double-leadthread, self-tapping, fully threadedNon-locking screws: cortical thread form, single-thread, self-tapping, fully threaded	Locking screws: cortical thread form, doublethread, self-tapping, fully threadedNon-locking screws: cortical thread form, singlethread, 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

Regulation Number and Section

§ 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.