One-Quarter Tubular Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius). The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

Straight Plates 2.4/2.7 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the foot, hand, wrist, and forearm (including radius) and arthrodesis of small bones of the foot and hand.

Reconstruction Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius)

Radius Distal Styloid Plate 2.4/2.7 is indicated for the fixation for fractures of the radial styloid that have metaphyseal comminution or as an adjunct to either volar of dorsal plate fixation when additional support of the radial styloid is required.

The Radius Proximal head plates 2.4/2.7 are indicated for extra-articular and intra-articular fractures of the proximal radius and multifragmented radial neck fractures.

The Radius Distal Volar Plates 2.4/2.7 are indicated for the fixation for fractures, fusions, or osteotomies of the distal radius.

One-Third Tubular Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), and fibula. The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

Reconstruction Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), wrist, and forearm (including radius), fibula, and calcaneus

Straight Plates 3.5 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the elbow (distal humerus and ulna), wrist, forearm (including radius), and fibula.

Tibia T-Plates 3.5 are indicated for buttressing of partial articular fractures and bone fragments of the distal tibia.

The Clavicle Superior Plates 3.5 are indicated for:

Fractures of the clavicle shaft
Fractures of the lateral clavicle
Malunions of the clavicle
Non-unions of the clavicle

The Clavicle Hook Plate 3.5 is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

The Humerus Proximal Plates 3.5 are indicated for the fixation of fractures, fracture dislocations, non-unions and osteotomies of the proximal humerus.

The Tibia Proximal Lateral Plates 3.5 are indicated for:

Split-type fractures of the lateral tibial plateau
Lateral split fractures with associated depressions
Pure central depression fractures
Split or depression fractures of the medial plateau

The Tibia Distal Medial Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia.

The Tibia Distal Anterolateral Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia.

The Humerus Distal Dorsolateral Plates 2.7/3.5 are indicated for

Intraarticular fractures of the distal humerus
Supracondylar fractures of the distal humerus
Non-unions of the distal humerus

The Humerus Distal Medial Plates 2.7/3.5 are indicated for

Intraarticular fractures of the distal humerus
Supracondylar fractures of the distal humerus
Non-unions of the distal humerus

The Ulna Proximal Olecranon Plates 3.5 are indicated for

Complex extra- and intra-articular olecranon fractures
Non-unions of the proximal ulna
Osteotomies
Simple olecranon fractures

Broad Curved Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia.

Broad Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia.

Narrow Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, and distal tibia.

T Plate 4.5/5.0 is intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

T-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

LL-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

Femur Distal Plates 4.5/5.0 are indicated for distal shaft fractures, supracondylar fractures, intraarticular fractures, and periprosthetic fractures of the distal femur

Tibia Proximal Lateral Plates 4.5/5.0 are indicated for proximal shaft fractures, metaphyseal fractures, intra-articular fractures and periprosthetic fractures of the proximal tibia.

Device Description

The Genostis Osteosynthesis System comprises of fracture fixation plates, corresponding screws and required surgical instruments. Different shapes and sizes are available to accommodate for different anatomical regions and locations of fractures. The plate screw interface is either locking, non-locking or, for some plates, realized by a combination hole offering both options (locking and non-locking).

All plates and screws are made of titanium alloy (Ti 6Al 4V ELI) according to ASTM F136 and ISO 5832-3.

The implants of the Genostis Osteosynthesis System are sterilized by radiation and are delivered sterile.

AI/ML Overview

The provided FDA 510(k) clearance letter for the Genostis Osteosynthesis System does not describe a study involving an AI/software device or human readers. Instead, it describes a traditional medical device (bone fixation plates and screws) and primarily references non-clinical (biomechanical and biocompatibility) testing to demonstrate substantial equivalence to predicate devices.

Therefore, many of the requested criteria related to AI/software performance, human reader studies, and ground truth establishment in a diagnostic context are not applicable to this document.

However, I can extract and structure the information that is relevant to the device's acceptance criteria based on the provided text, particularly concerning non-clinical testing.

Here's the breakdown based on the information available:

Acceptance Criteria and Study for Genostis Osteosynthesis System

The Genostis Osteosynthesis System is a traditional medical device (bone fixation plates and screws), not an AI/software diagnostic device. As such, the "acceptance criteria" and "study" proving it meets them are primarily based on non-clinical engineering and biological tests, not AI performance metrics or human-in-the-loop diagnostic studies.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Standard	Acceptance Criteria	Reported Device Performance
Material Biocompatibility	Cytotoxicity (ISO 10993-5)	Satisfactory bio-compatibility endpoints	Performed; results satisfactory.
	Sensitization (ISO 10993-10)	Satisfactory bio-compatibility endpoints	Performed; results satisfactory.
	Irritation/Intracutaneous Reactivity (ISO 10993-23)	Satisfactory bio-compatibility endpoints	Performed; results satisfactory.
	Chemical Characterization (ISO 10993-18)	Satisfactory bio-compatibility endpoints	Performed; results satisfactory.
	Toxicological Risk Assessment	Satisfactory bio-compatibility endpoints	Performed; results satisfactory.
	Bacterial Endotoxin Testing	Acceptable endotoxin levels	Performed; results satisfactory.
Mechanical Performance	Screw Performance (ASTM F543)	Satisfactory mechanical performance	Performed; results satisfactory.
	Plate Performance (ASTM F382)	Satisfactory mechanical performance	Performed; results satisfactory.
Packaging & Sterilization	Sterility (Radiation)	Device must be sterile at delivery	Implants are sterilized by radiation and delivered sterile. Test conducted on final sterile product.
General	Substantial Equivalence to Predicates	All non-clinical testing demonstrates substantial equivalence.	All testing indicates substantial equivalence to predicates.

Note: The document states "All results were satisfactory" for all tests, indicating the device met the pre-defined acceptance criteria for each test.

2. Sample Sizes Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact number of units or samples used for each biomechanical or biocompatibility test. It generally states that testing was "performed" and "conducted on final sterile product."
Data Provenance: Not explicitly stated as "country of origin," but testing would be performed in a controlled laboratory environment. The tests are non-clinical (biomechanical and biocompatibility), not data from patients. The study is by nature prospective in that new manufactured devices were tested to meet the standards, not a retrospective analysis of existing data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. This is a medical device (hardware) clearance, not an AI/software diagnostic device that requires expert ground truth for interpretation of medical images or other diagnostic data. The "ground truth" here is the adherence to established engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

Not Applicable. As this is non-clinical mechanical and biocompatibility testing, there is no "adjudication" in the sense of reconciling expert opinions on diagnostic findings. The results are quantitative and objective measurements against established standard thresholds.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not Applicable. MRMC studies are for evaluating clinical interpretation of diagnostic results, typically with AI assistance. This device is a physical implant, not a diagnostic tool or AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This pertains to AI algorithm performance. The device is a bone fixation system and does not rely on an algorithm for its primary function.

7. The Type of Ground Truth Used

Pre-defined Standards and Controls: The "ground truth" for this device's performance is established by well-defined, internationally recognized (ISO) and American (ASTM) standards for material properties, mechanical strength, and biocompatibility. The device must perform within the specified parameters of these standards. For example, screws must meet certain torque resistance (ASTM F543), and plates must meet specific load-sharing characteristics (ASTM F382).

8. The Sample Size for the Training Set

Not Applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. There is no "training set" for this type of medical device clearance. The design and manufacturing processes are established based on engineering principles and existing predicate device designs, with performance validated against the standards mentioned above.

Summary

FDA 510(k) Clearance Letter - Genostis Osteosynthesis System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

June 27, 2025

Genostis AF
℅ Cheryl Wagoner
Principal Consultant/ Owner Wagoner Consulting LLC
Wagoner Consulting LLC
5215 Crosswinds Drive
Wilmington, North Carolina 28409

Re: K242988
Trade/Device Name: Genostis Osteosynthesis 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, HWC
Dated: May 23, 2025
Received: May 23, 2025

Dear Cheryl Wagoner:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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K242988 - Cheryl Wagoner Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K242988 - Cheryl Wagoner Page 3

assistance/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,

Thomas Mcnamara -S

For: Christopher Ferreira, M.S.
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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K242988

Device Name
Genostis Osteosynthesis System

Indications for Use (Describe)
Intended Use: Plate and screw Implants are intended for temporary fixation, correction or stabilization of bones in various anatomical regions.

Reconstruction Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius)

The Radius Proximal head plates 2.4/2.7 are indicated for extra-articular and intra-articular fractures of the proximal radius and multifragmented radial neck fractures.

The Radius Distal Volar Plates 2.4/2.7 are indicated for the fixation for fractures, fusions, or osteotomies of the distal radius.

Reconstruction Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), wrist, and forearm (including radius), fibula, and calcaneus

Straight Plates 3.5 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the elbow (distal humerus and ulna), wrist, forearm (including radius), and fibula.

Tibia T-Plates 3.5 are indicated for buttressing of partial articular fractures and bone fragments of the distal tibia.

The Clavicle Superior Plates 3.5 are indicated for:

Fractures of the clavicle shaft
Fractures of the lateral clavicle
Malunions of the clavicle
Non-unions of the clavicle

The Clavicle Hook Plate 3.5 is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

FORM FDA 3881 (8/23)
Page 1 of 3
PSC Publishing Services (301) 443-6740 EF
Page 162

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Page 163

The Humerus Proximal Plates 3.5 are indicated for the fixation of fractures, fracture dislocations, non-unions and osteotomies of the proximal humerus.

The Tibia Proximal Lateral Plates 3.5 are indicated for:

Split-type fractures of the lateral tibial plateau
Lateral split fractures with associated depressions
Pure central depression fractures
Split or depression fractures of the medial plateau

The Tibia Distal Medial Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia.

The Tibia Distal Anterolateral Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia.

The Humerus Distal Dorsolateral Plates 2.7/3.5 are indicated for

Intraarticular fractures of the distal humerus
Supracondylar fractures of the distal humerus
Non-unions of the distal humerus

The Humerus Distal Medial Plates 2.7/3.5 are indicated for

Intraarticular fractures of the distal humerus
Supracondylar fractures of the distal humerus
Non-unions of the distal humerus

The Ulna Proximal Olecranon Plates 3.5 are indicated for

Complex extra- and intra-articular olecranon fractures
Non-unions of the proximal ulna
Osteotomies
Simple olecranon fractures

Broad Curved Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia.

Broad Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia.

Narrow Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, and distal tibia.

T-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia.
The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

LL-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia.
The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

FORM FDA 3881 (8/23)
Page 2 of 3
PSC Publishing Services (301) 443-6740 EF
Page 163

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Page 164

Femur Distal Plates 4.5/5.0 are indicated for distal shaft fractures, supracondylar fractures, intraarticular fractures, and periprosthetic fractures of the distal femur

Tibia Proximal Lateral Plates 4.5/5.0 are indicated for proximal shaft fractures, metaphyseal fractures, intra-articular fractures and periprosthetic fractures of the proximal tibia.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23)
Page 3 of 3
PSC Publishing Services (301) 443-6740 EF
Page 164

Page 7

510(k) Summary
Prepared on: 2025-05-22

Contact Details

21 CFR 807.92(a)(1)

Field	Information
Applicant Name	Genostis AG
Applicant Address	Kirchbergstrasse 160 Burgdorf 3400 Switzerland
Applicant Contact Telephone	+41764559774
Applicant Contact	Dr. Sabine Söhndel
Applicant Contact Email	sabine.soehndel@genostis.com
Correspondent Name	Wagoner Consulting LLC
Correspondent Address	5215 Crosswinds Drive Wilmington NC 28409 United States
Correspondent Contact Telephone	910-386-9019
Correspondent Contact	Mrs. Cheryl Wagoner
Correspondent Contact Email	cheryl@wagonerconsultingllc.com

Device Name

21 CFR 807.92(a)(2)

Field	Information
Device Trade Name	Genostis Osteosynthesis System
Common Name	Single/multiple component metallic bone fixation appliances and accessories
Classification Name	Plate, Fixation, Bone
Regulation Number	888.3030
Product Code(s)	HRS, HWC

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K001945	Synthes LCP Low Bend Medial Distal Tibia Plates 3.5mm	HRS
K000682	Synthes 4.5 mm Narrow LCP Plates and 5.00 mm Locking Screw	HRS
K000684	Synthes LCP Olecranon Plate and Synthes 3.5 mm Locking Screw	HRS
K010321	Synthes Quarter Tubular Plate 2.7 with Collar	HRS
K010766	LCP L-Buttress Plates 4.5/5.0	HRS
K011335	Synthes 3.5 mm LCP one-third tubular plate	HRS

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Page 8

Predicate #	Predicate Trade Name	Product Code
K030597	Synthes LCP Proximal Tibial Plate 3.5, Lateral	HRS
K033995	Synthes LCP Distal Humerus Plate , dorsolateral with support	HRS
K040777	Synthes LCP Proximal Radius Plates 2.4	HRS
K041911	Synthes 4.5 mm Curved Broad LCP Plates	HRS
K052390	Synthes LCP Proximal Lateral Tibia Plate 4.5/5.0	HRS
K061753	Synthes LCP Clavicle Hook Plate	HRS
K062564	Synthes LCP Distal Femur Plates	HRS
K063049	Synthes LCP plate 2.7 straight Synthes 2.4/2.7 mm locking screw	HRS
K073186	Synthes LCP Superior Clavicle Plate	HRS
K080522	Synthes 3.5 mm T Plate	HRS
K082625	Synthes PHILOS long-proximal diaphyseal humeral plate 3.5	HRS
K092812	Synthes LCP Anterolateral Distal Tibia Plate 3.5	HRS
K102998	Acumed Acu-Loc Plating System	HRS
K112583	Synthes 2.7/3.5 mm Cortex Screw	HWC
K161616	Synthes 4.5 mm Cortex Screw	HWC
K071715	Acumed Acu_LOC 2 Plating System	HRS

Device Description Summary

21 CFR 807.92(a)(4)

All plates and screws are made of titanium alloy (Ti 6Al 4V ELI) according to ASTM F136 and ISO 5832-3.

The implants of the Genostis Osteosynthesis System are sterilized by radiation and are delivered sterile.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Intended Use: Plate and screw Implants are intended for temporary fixation, correction or stabilization of bones in various anatomical regions.

Reconstruction Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius)

Page 266

Page 9

The Radius Proximal head plates 2.4/2.7 are indicated for extra-articular and intra-articular fractures of the proximal radius and multifragmented radial neck fractures.

The Radius Distal Volar Plates 2.4/2.7 are indicated for the fixation for fractures, fusions, or osteotomies of the distal radius.

Reconstruction Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), wrist, and forearm (including radius), fibula, and calcaneus

Straight Plates 3.5 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the elbow (distal humerus and ulna), wrist, forearm (including radius), and fibula.

Tibia T-Plates 3.5 are indicated for buttressing of partial articular fractures and bone fragments of the distal tibia.

The Clavicle Superior Plates 3.5 are indicated for:

Fractures of the clavicle shaft
Fractures of the lateral clavicle
Malunions of the clavicle
Non-unions of the clavicle

The Clavicle Hook Plate 3.5 is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

The Humerus Proximal Plates 3.5 are indicated for the fixation of fractures, fracture dislocations, non-unions and osteotomies of the proximal humerus.

The Tibia Proximal Lateral Plates 3.5 are indicated for:

Split-type fractures of the lateral tibial plateau
Lateral split fractures with associated depressions
Pure central depression fractures
Split or depression fractures of the medial plateau

The Tibia Distal Medial Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia.

The Tibia Distal Anterolateral Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia.

The Humerus Distal Dorsolateral Plates 2.7/3.5 are indicated for

Intraarticular fractures of the distal humerus
Supracondylar fractures of the distal humerus
Non-unions of the distal humerus

The Humerus Distal Medial Plates 2.7/3.5 are indicated for

Intraarticular fractures of the distal humerus
Supracondylar fractures of the distal humerus
Non-unions of the distal humerus

The Ulna Proximal Olecranon Plates 3.5 are indicated for

Complex extra- and intra-articular olecranon fractures
Non-unions of the proximal ulna
Osteotomies
Simple olecranon fractures

Broad Curved Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia.

Broad Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia.

Narrow Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, and distal tibia.

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Page 10

Femur Distal Plates 4.5/5.0 are indicated for distal shaft fractures, supracondylar fractures, intraarticular fractures, and periprosthetic fractures of the distal femur

Tibia Proximal Lateral Plates 4.5/5.0 are indicated for proximal shaft fractures, metaphyseal fractures, intra-articular fractures and periprosthetic fractures of the proximal tibia.

Substantial Equivalence Comparison

21 CFR 807.92(a)(6)

The indications between the Subject device and its predicates are the same with minor wording differences.

Technological Comparison

21 CFR 807.92(a)(6)

The Subject and predicate devices have the same technological characteristics including similar designs, materials, chemical composition and principle of operation.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

This application includes biomechanical and biocompatibility testing per appropriate ISO and ASTM standards. All results were satisfactory. All standards are included in the standards section of this application.

Bacterial endotoxin testing was performed. Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), and Irritation/Intracutaneous reactivity (ISO 10993-23) were performed. Chemical characterization (ISO 10993-18) and toxicological risk assessment were also performed as part of the biocompatibility risk assessment. Screw performance testing per ASTM F543 and plate performance testing per ASTM F382 were performed.

All testing indicates that the Subject device is substantially equivalent to the predicates presented in this application. Each test was conducted on final sterile product.

For clarity, the buttress plates include: One Third Tubular Plates 3.5, One Quarter Tubular Plates 2.4/2.7, Tibia T-Plate 3.5, T Plate 4.5/5.0, T-Buttress Plate 4.5/5.0, L-Buttress Plate 4.5/5.0.

Indications for Use Comparison

21 CFR 807.92(a)(5)

The indications between the Subject device and its predicates are the same with minor wording differences.

Technological Comparison

21 CFR 807.92(a)(6)

The Subject and predicate devices have the same technological characteristics including similar designs, materials, chemical composition and principle of operation.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

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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.