(274 days)
No.
The device description and indications for use clearly define it as a system of physical orthopaedic implants (plates and screws) for fracture fixation. There is no mention of any software, algorithms, or data processing, which would be necessary for an AI model.
Yes.
Explanation: The device is a system of plates and screws intended for temporary fixation, correction, or stabilization of bones for fractures, osteotomies, malunions, and nonunions, which are all therapeutic purposes.
No
Explanation: The device is an osteosynthesis system intended for temporary fixation, correction, or stabilization of bones. This is a therapeutic function, not a diagnostic one.
No
The device is described as "fracture fixation plates, corresponding screws and required surgical instruments" made of "titanium alloy". This clearly indicates a physical implant and surgical tools, not a software-only device. The 'Not Found' entries for mentions of AI, DNN, ML, image processing, input imaging modality, and performance study metrics further confirm it is not a software device.
No.
The device is an implantable plate and screw system for fracture fixation, which is an invasive surgical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
Intended Use: Plate and screw Implants are intended for temporary fixation, correction or stabilization of bones in various anatomical regions.
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.
Product codes
HRS, HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones in various anatomical regions, foot, hand, wrist, forearm (including radius), elbow (distal humerus and ulna), fibula, calcaneus, clavicle shaft, lateral clavicle, proximal humerus, lateral tibial plateau, distal tibia, humerus, femur
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
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.
Key Metrics
Not Found
Predicate Device(s)
K001945, K000682, K000684, K010321, K010766, K011335, K030597, K033995, K040777, K041911, K052390, K061753, K062564, K063049, K073186, K080522, K082625, K092812, K102998, K112583, K161616, K071715
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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-
Page 3
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.
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.
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 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.
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
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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)
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.
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.
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)
Page 266
Page 9
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.
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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.
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)
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.
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