OGmend Implant System

DEN180065 · Woven Orthopedic Technologies, LLC · QAC · May 1, 2020 · Orthopedic

Device Facts

• Record ID: DEN180065
• Device Name: OGmend Implant System
• Applicant: Woven Orthopedic Technologies, LLC
• Product Code: QAC · Orthopedic
• Decision Date: May 1, 2020
• Decision: DENG
• Submission Type: Direct
• Regulation: 21 CFR 888.3043
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OGmend® Implant System is intended for use with screws as part of a fracture fixation plate system in long bones in rescue scenarios where the screw has lost purchase due to screw loosening, back out, or breakage and the stability of the overall construct is at risk. The OGmend® Implant System is for use in skeletally mature patients.

Device Story

Sterile, single-use woven PET sleeve; 6.5mm ID, 7.5mm OD, 100mm length (cut intraoperatively). Used in long bone fracture repair when screw purchase is lost. Surgeon inserts sleeve into prepared bone pilot hole; new bone screw is driven through sleeve inner diameter. Interference fit restores stability to plate-screw construct. Evaluated via bench testing (axial pullout, cyclic loading, insertion/extraction torque) and ovine models (metatarsal/spine). Provides mechanical stability for fracture healing; PET material biocompatible. Intended for use by orthopedic surgeons in clinical settings.

Clinical Evidence

No human clinical data. Safety and effectiveness supported by four animal studies (ovine metatarsal and lumbar spine). Spine model (n=54) compared treatment (failed screw + OGmend) to positive (standard screw) and negative (failed screw) controls. Endpoints included axial pullout force, insertion/extraction torque, pullout stiffness, kinematics, and histopathology at 0, 12, and 24 weeks. Results demonstrated sufficient mechanical stability for healing and no significant adverse biological reaction.

Technological Characteristics

Screw sleeve bone fixation device; metallic; designed for interference fit between screw threads and bone. Requires biocompatibility, non-pyrogenicity, and sterility validation. Mechanical device; no software, electronics, or energy source.

Indications for Use

Indicated for skeletally mature patients requiring rescue of bone screws that have lost purchase (loosening, back-out, or breakage) within a fracture fixation plate system in long bones.

Regulatory Classification

Identification

A screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone and provides increased surface area to create an interference fit to restore stability of the implant construct.

Special Controls

In combination with the general controls of the FD&C Act, the screw sleeve bone fixation device is subject to the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) In vivo performance testing under anticipated conditions of use must demonstrate: (i) The device provides sufficient stability to allow for fracture healing; and (ii) A lack of adverse biologic response to the implant through histopathological and histomorphometric assessment. (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must: (i) Assess the stability of the device in a rescue screw scenario; (ii) Demonstrate that the device can be inserted and removed without damage to the implant or associated hardware; (iii) Demonstrate the device can withstand dynamic loading without device failure; and (iv) Characterize wear particle generation. (3) The device must be demonstrated to be biocompatible. (4) The device must be demonstrated to be non-pyrogenic. (5) Performance data must demonstrate the sterility of the device. (6) Performance data must support the labeled shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the established shelf life. (7) Labeling must include: (i) A detailed summary of the device technical parameters; (ii) Information describing all materials of the device; (iii) Instructions for use, including device removal; and (iv) A shelf life.

Submission Summary (Full Text)

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### DE NOVO CLASSIFICATION REQUEST FOR OGMEND® IMPLANT SYSTEM

### REGULATORY INFORMATION

FDA identifies this generic type of device as:

Screw sleeve bone fixation device: A screw sleeve bone fixation device is intended to be implanted in conjunction with a non-resorbable, metallic bone screw where the screw has lost purchase due to loosening, backout, or breakage. The device fits between the screw threads and surrounding bone, and provides increased surface area to create an interference fit to restore stability of the implant construct.

NEW REGULATION NUMBER: 21 CFR 888.3043

CLASSIFICATION: Class II

PRODUCT CODE: QAC

### BACKGROUND

DEVICE NAME: OGmend® Implant System

SUBMISSION NUMBER: DEN180065

DATE DE NOVO RECEIVED: December 13, 2018

### SPONSOR INFORMATION:

Woven Orthopedic Technologies, LLC 63 E. Center Street Manchester, Connecticut 06040

### INDICATIONS FOR USE

The OGmend® Implant System is indicated as follows:

The OGmend® implant system is for the use with screws as part of a fracture fixation plate system in long bones in rescue scenarios where the screw has lost purchase due to screw loosening, back out, or breakage and the stability of the plate construct is at risk. The OGmend® Implant System is for use in skeletally mature patients.

### LIMITATIONS

The sale, distribution, and use of the OGmend® Implant System is restricted to prescription use in accordance with 21 CFR 801.109.

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The safety and effectiveness of the OGmend® Implant System has not been established for use with non-metallic, resorbable, or self-tapping screws.

The OGmend® Implant System should not be used with stand-alone screws, joint arthroplasty systems, and spinal fixation procedures.

The OGmend® Implant System should not be used in a situation where other rescue techniques (i.e., rescue screw, repositioning of bone plating system or stand-alone screw) will provide a better patient outcome.

The OGmend® Implant System has not been tested in patients with osteoporosis, osteopenia, diabetes, nor in patients who smoke or who have any other metabolic bone diseases.

PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.

# DEVICE DESCRIPTION

The OGmend® Implant System is a sterile, single-use device intended to provide supplemental fixation to restore stability if the screw/bone interface of a plate and screw system becomes mechanically compromised. When inserted into a prepared bone pilot hole, the OGmend® Implant System is designed to use the principles of interference fit to serve as a rescue technology to secure a bone screw and stabilize the fracture construct. The OGmend® Implant System is manufactured from woven polyethylene terephthalate (PET), with an inner diameter of 6.5mm and an outer diameter of 7.5mm, and can be used with screws ranging in diameter from 3.5mm to 6.5mm. The OGmend® Implant System is 100mm in length and is cut intraoperatively to the appropriate length.

Image /page/1/Picture/7 description: The image shows two metal objects, one above the other, against a dark background. The top object is a cylindrical pin with a textured surface, while the bottom object is a screw with a pointed tip and threading along its length. The pin appears to have a smooth section at one end, possibly for insertion or attachment.

Figure 1: View of OGmend® Implant System on sample screw

When a screw loses stability due to loosening, backout, or breakage, the OGmend® Implant System is intended to restore stability. The device is placed into a prepared hole after removal of the failed screw, and a new screw is inserted though the inner diameter of the OGmend® Implant

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System, in order to generate mechanical interferences and improve the stability of the screw and bone-plate construct.

Image /page/2/Figure/1 description: The image shows three diagrams illustrating the process of inserting a screw into a bone. The first diagram, labeled "A. Plate and Pilot Hole," shows a plate placed on top of the bone with a pilot hole drilled through the plate and into the bone. The second diagram, labeled "B. Insert OGmend," shows an OGmend device inserted into the pilot hole. The third diagram, labeled "C. Insert Screw," shows a screw inserted into the OGmend device.

# Figure 2: Illustration of placement of OGmend® Implant System in hole during the repair of a failed screw on a bone plate system.

# SUMMARY OF NONCLINICAL/BENCH STUDIES

### BIOCOMPATIBILITY/MATERIALS

The OGmend® Implant System is manufactured from the following materials:

### Table 1: Device Materials

| Description | Material | Direct Patient<br>Contact | Contact Duration |
|---------------------------|----------------------------|---------------------------|------------------|
| OGmend®<br>Implant System | Polyethylene Terephthalate | Yes | (b)(4) |
| Inserter<br>Instrument | (b)(4) | Yes | (b)(4) |

Biocompatibility Testing is described in the table below.

### Table 2: Biocompatibility Testing

| ISO 10993 Endpoint | Test Performed | Endpoint Met |
|-------------------------------------------|----------------|--------------|
| Cytotoxicity | Yes | Yes |
| Sensitization | Yes | Yes |
| Irritation / Intracutaneous<br>Reactivity | Yes | Yes |
| Acute Systemic Toxicity | Yes | Yes |
| Material-Mediated<br>Pyrogenicity | Yes | Yes |

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| Subacute / Subchronic<br>Toxicity | Yes | Yes |
|-----------------------------------|-----|-----|
| Genotoxicity | Yes | Yes |
| Implantation | Yes | Yes |
| Chronic Toxicity | Yes | Yes |
| Carcinogenicity | Yes | Yes |

Additional in vivo studies data were leveraged to address biocompatibility of the OGmend® Implant System (See Animal Testing section below). In conjunction with the CDRH Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", the in vivo testing and ISO 10993 testing provided, was used to demonstrate the biocompatibility of the device.

# SHELF LIFE/STERILITY

The subject device is a single use device and is provided sterile to the end user. The sterilization method is gamma radiation at a dose of 25 kGy. Sterilization was validated using the VDmax method as per ISO 11137, and achieved a Sterility Assurance Level (SAL) of 10-6. The subject device and instruments are packaged together in sealed double-blister Tyvek pouches.

Sterilized samples accelerated-aged to ""months, and real-time aged to """months were used to determine the shelf life of the device. Distribution testing and package integrity testing (bubble/leak test, ASTM F2096), and seal strength testing (ASTM F88/F88M) were used to validate the sterile shelf life of device. Non-clinical performance testing of the implant (See Table 3) was used to assess the performance shelf life of the device. The testing confirmed a (b)(4) shelf life.

The following standards were utilized in the validation of the sterilization and shelf-life:

- ANSI/AAMI/ISO 11137-1:2006: Sterilization of health care products -. Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ANSI/AAMI/ISO 11137-2:2012: Sterilization of Health Care Products -Radiation ● - Establishing the Sterilization Dose - Method VDmax25
- ISO 11737-1 2006/(R)2011 Sterilization of medical devices Microbiological ● methods - Part 1: determination of a population of microorganisms on products
- ANSI/AAMI/ISO 11737-2:2009 Sterilization of medical devices -● Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- ASTM F88/ F88M-15: Standard Test Method for Seal Strength of Flexible ● Barrier Materials
- . ASTM F1886/ F1886M-09 (2013): Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection

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- ANSI/AAMI/ISO11607-1:2006: Packaging for terminally sterilized medical . devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems
- . ANSI/AAMI/ISO11607-2:2006: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing, and assembly processes
- . ASTM F1980, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM F 1140:2007, Standard Test Methods for Internal Pressurization Failure ● Resistance of Unrestrained Packages.
- ASTM F2096-2004. Standard Test Method for Detecting Gross Leaks in Medical ● Packaging by Internal Pressurization (Bubble Test)
- ASTM D-4332/1991, Standard practice for conditioning containers, packages, or ● packaging components for testing
- ISTA 2A-2011, Partial Simulation Performance Tests ●

# MAGNETIC RESONANCE (MR) COMPATIBILITY

The subject device was not evaluated for safety in a (b)(4) Environment. The device is manufactured from a non-ferromagnetic, non-metallic, and radiofrequency transparent material, PET; however, as it is intended to be used with metallic bone plate and screw systems, the following precaution is included in the labeling:

- . There may be concerns regarding the MR safety of the metallic hardware (i.e., plates and screws) used in conjunction with the OGmend® Implant System.
# PERFORMANCE TESTING - BENCH

| Test | Purpose | Method | Acceptance Criteria | Results |
|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Screw Axial<br>Pullout | This test is intended<br>to assess if the<br>subject device<br>provides improved<br>stability compared<br>to an alternate<br>treatment for a<br>failed screw. | To simulate a rescue scenario, a<br>3.5 mm pilot hole was made in 20<br>pcf Sawbone. The device was<br>then implanted in combination<br>with a 3.5 mm screw. The screw<br>was then pulled axially until<br>failure as per ASTM F543. 4.0<br>mm screws were inserted into 3.5<br>mm pilot holes to simulate<br>placing a larger screw in a failed<br>screw hole as a control. | The axial pullout<br>force of the screw in<br>combination with the<br>sleeve must be<br>equivalent to or<br>greater than the<br>pullout force for a<br>rescue screw alone. | Test results show<br>that the force<br>required to pull<br>out a 3.5 mm<br>screw with the<br>OGmend®<br>Implant System<br>in place exceeded<br>the force required<br>to pull out a 4.0<br>mm screw<br>without the<br>OGmend®<br>Implant System.<br>The acceptance<br>criteria were met. |
| Test | Purpose | Method | Acceptance Criteria | Results |
| | | (b) (4) | | |
| | | Figure 3: Test setup for Axial<br>Pullout | | |
| Sleeve Dynamic<br>Axial Loading,<br>Pullout and<br>Removal/<br>Extraction<br>Torque | This test is intended<br>to assess if dynamic<br>loading would<br>damage the implant<br>and/or cause a<br>reduction in pullout<br>strength. | A control group (without the<br>OGmend® Implant System) and<br>treatment group (with the<br>OGmend® Implant System) were<br>defined. (b) (4)<br><br>Axial loading is considered to<br>constitute the worst-case clinical<br>loading scenario as compression<br>plates are designed to generate<br>axial loading on the screw, and<br>the resultant force on the screw<br>would be reduced by transfer of<br>some load to the plate.<br><br>Each screw was sinusoidally<br>loaded between $(b)$ N and $(b)$ % of<br>the pullout force determined from | After (b) (4) cycles,<br>there should be no<br>decrease in pullout<br>values or damage to<br>the device. | The test results<br>showed no<br>decrease in axial<br>pullout force or<br>removal torque in<br>either the control<br>group or in the<br>OGmend®<br>Implant System<br>treatment group.<br><br>This testing<br>demonstrated<br>that cyclic<br>loading did not<br>negatively affect<br>the mechanical<br>strength of the<br>device or the<br>stability of the<br>interference fit. |
| Test | Purpose | Method | Acceptance Criteria | Results |
| | | static testing for a total of (b) (4)<br>cycles at a rate of Hz. For<br>reference, the pullout force was<br>re-evaluated during this testing to<br>determine the correct (b)% value.<br>The (b)% pullout force value for<br>the subject device was (b) N and<br>was (b) N for the control.<br><br>At the completion of(b) (4)<br>cycles, removal torque and<br>pullout testing were conducted<br>per ASTM F543. | | |
| Sleeve Insertion<br>Force | This test is intended<br>to evaluate the force<br>required to insert the<br>sleeve compared to<br>the force required to<br>insert the sleeve<br>manually during a<br>surgical procedure. | The axial force needed to push<br>the sleeve into a pilot hole using<br>an inserter tool in (b) pcf bone<br>foam was measured. Testing was<br>performed with both a 3.5 mm<br>and 6.5 mm pilot hole to represent<br>the smallest and largest potential<br>holes compatible with the device.<br><br>To assess the load needed to<br>cause damage to the sleeve, a<br>probe was pressed through the<br>sleeve against the distal tip at a<br>constant rate until failure of the<br>sleeve occurred.<br>(b) (4)<br><br>Figure 4: Test setup for sleeve<br>mechanical strength test | No more than(b) N<br>should be required to<br>insert the OGmend®<br>Implant System. This<br>was based on an<br>assessment of load<br>needed to damage the<br>device with a margin<br>of safety. | For both a 3.5<br>mm and a 6.5<br>mm pilot hole, it<br>required less than<br>(b) N to insert the<br>device (b) (4)<br>N in the 3.5 mm<br>hole, and(b) (4)<br>N in the 6.5 mm<br>hole). This<br>compares to an<br>average force of<br>(b) .1 N needed<br>to rupture the<br>distal end of the<br>sleeve.<br><br>This<br>demonstrated<br>that the device<br>can be<br>successfully<br>inserted into<br>bone using the<br>provided surgical<br>technique and<br>instruments<br>without damage<br>to the device. |
| Screw Removal/<br>Extraction<br>Torque | This test is intended<br>to assess the ability<br>of the screw to be<br>inserted and<br>extracted when used<br>with the OGmend®<br>Implant System<br>compared to a<br>traditional, fully<br>threaded bone screw | The investigational cohort,<br>consisting of the OGmend®<br>Implant System and screw, was<br>tested with two screw diameters<br>(3.5mm and 6.5mm) in 20 pcf<br>sawbone. Pilot holes were made<br>in the sawbone, and the sleeve<br>and screw were implanted<br>following the surgical technique.<br>During insertion, torque was | The torque required<br>to insert and remove<br>the screw with the<br>OGmend® Implant<br>System in place must<br>be less than the<br>torsional strength of<br>the screw | The OGmend®<br>Implant System<br>did increase the<br>torque needed to<br>insert and<br>remove the<br>screw. The<br>torque to insert<br>the screw<br>increased from<br>0.025 Nm to |
| Test | Purpose | Method | Acceptance Criteria | Results |
| | OGmend® Implant<br>System. The intent<br>of the test is to<br>demonstrate that the<br>interference<br>generated by the<br>implant did not<br>increase the<br>insertion/removal<br>torque sufficientlybreakage of the<br>screw during<br>implantation or<br>removal, or not<br>allow for proper<br>implantation of the<br>screw. | insertion, the screw was then<br>removed while measuring torque,<br>as per ASTM F543-17.<br><br>The torsional strength of the<br>screw was assessed by torqueing<br>the screw until failure as per<br>ASTM F543.<br><br>(b) (4)<br>Image: Figure 5: Test setup for insertion torque testing. | | 0.133 Nm (3.5<br>mm) and from<br>0.123 Nm to<br>0.651 Nm (6.5<br>mm screw).<br><br>Similarly, the<br>torque to extract<br>the screw<br>increased from<br>0.025 Nm to<br>0.180 Nm (3.5<br>mm) and from<br>0.137 to 0.803<br>Nm (6.5 mm<br>screws)<br><br>While there was<br>an increase in the<br>torque required<br>to implant and<br>remove the<br>screw, the torque<br>was still<br>significantly less<br>than the yield<br>torque of the<br>screws being<br>tested, indicating<br>there is no risk of<br>screw failure<br>during insertion<br>and removal. |
| Durability of<br>Sleeve during<br>Screw<br>Implantation | This test is intended<br>to assess if the<br>OGmend® Implant<br>System can be<br>inserted into the<br>bone without<br>damage of the<br>device, using the<br>provided<br>instruments, in<br>preparation for the<br>placement of a<br>screw. | (b) (4) | Screw pullout force<br>following repeated<br>insertions must not be<br>reduced compared to<br>prior axial pullout<br>testing. | Testing showed<br>no reduction in<br>pullout strength<br>of a screw<br>compared to<br>baseline. This<br>indicates the<br>device can<br>withstand the<br>handling of<br>surgery without<br>damage that<br>could affect its<br>mechanical<br>performance. |
| Wear Particle<br>Generation | This test is intended<br>to assess if the<br>sleeve can withstand<br>screw insertion and<br>cyclic loading | (b) (4) | The device should<br>not sustain damage<br>such that it fails to<br>perform its intended<br>function, and wear | Assessment of<br>images found no<br>significant<br>damage occurred<br>to the structural |
| Test | Purpose | Method | Acceptance Criteria | Results |
| | without damage.<br>There is potential<br>for the screw threads<br>to generate wear<br>particles during<br>insertion, or during<br>toggling during<br>cyclic loading. | layer was used. The device was<br>implanted following the surgical<br>technique, and a 325 N load was<br>applied at R = 10 at 5 Hz for 1<br>million cycles. Following testing,<br>the test block and specimens were<br>assessed for particulate<br>generation, and high-resolution<br>photographs of the sleeve were<br>taken to assess if damage<br>occurred to the device. | particles generated<br>should be fully<br>characterized. | integrity of the<br>device.<br><br>A total<br>particulate<br>measure of 0.12<br>$\pm$ 0.24 (range<br>0.005 to 0.661)<br>mg of PET was<br>recorded in the<br>dynamically<br>loaded samples,<br>compared to 0.21<br>$\pm$ 0.23 (range<br>0.026 to 0.654)<br>in the control<br>group. Total<br>particle count<br>was different<br>between groups,<br>with an average<br>of 3.26E4 $\pm$<br>2.70E4 particles<br>in the toggle<br>group and<br>1.26E6 $\pm$ 1.64E6<br>in the control<br>group. |

### Table 3: Summarv of Bench Testing

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# PERFORMANCE TESTING - ANIMAL AND/OR CADAVER

The sponsor conducted and provided a total of four (4) animal studies to support safety and effectiveness of the subject device. Three of these studies were conducted in sheep metatarsals, and the fourth study was conducted in the sheep lumbar spine to evaluate vertebral pedicle screw fixation for spinal fusion. While the sponsor is not proposing any spinal indications or sleeve compatibility with pedicle screws in this submission, they included this animal study for further evaluation of bony response to PET in a load-bearing scenario.

The high-level protocol information for each of these animal studies is shown in the table below:

# Table 4: Overview of Animal Studies

| | Screw Model | Osteotomy Model | Osteotomy Model | Spine Model |
|--------------|---------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------------|
| Animal Model | Ovine Metatarsal | Ovine Metatarsal<br>with Osteotomy | Ovine Metatarsal<br>with Osteotomy | Ovine Lumbar<br>Spine Fusion |
| Sample Size | 10 Animals | 4 Animals | 18 Animals + 6<br>Cadaveric | 54 Animals |
| Construct | Screw only (6<br>Cortical and 2<br>Cancellous screws<br>per animal) | 9-Hole Plate (7<br>Cortical and 2<br>Cancellous screws<br>per plate) | 9-Hole Plate (7<br>Cortical and 2<br>Cancellous screws<br>per plate) | L2-L3 Fusion (4<br>pedicle screws and<br>2 rods) |

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| | Screw Model | Osteotomy Model | Osteotomy Model | Spine Model |
|---------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Cohorts | Control: Bone<br>Screw (n=5)<br>Treatment: Screws<br>with OGmend®<br>Implant System<br>(n=5) | Control: Plate and<br>Screw Alone (n=2)<br>Treatment: Plate<br>and Screw with<br>OGmend® Implant<br>System (n=2) | Control: Cadaveric<br>Sheep (n=6)<br>Treatment: Plate<br>and Screw with<br>OGmend® Implant<br>System(n=18) | Positive Control (n<br>= 18)<br>Negative Control<br>(n=18)<br>Treatment<br>(Negative Control<br>with OGmend®<br>Implant System, n=<br>18) |

For the Spine model, the positive control consisted of a standard screw, in which a 4.5 mm screw was placed in a 3.5 mm pilot hole. The negative screw represented a "failed" screw, in which a 4.5 mm screw was placed in a 4.5 mm pilot hole. The treatment group were also prepared with a 4.5 mm pilot hole and 4.5 mm screw, however the OGmend® Implant System was used in conjunction with the screw. Data from the pivotal spine study was used in the final safety and efficacy determination. The sponsor provided assessment of six animals at 0, 12, and 24 weeks. The final determination of the safety and effectiveness of the device was based upon data generated by the Spine Model study. Data provided in the Spine Model Study used to determine the safety and efficacy of the device included:

- Axial Pullout force of screws at each time point to assess the fixation strength of the . implant compared to controls.
Image /page/9/Figure/3 description: The image is a bar graph titled "Screw Pull Out Force" that shows the pullout force in Newtons on the y-axis and the treatment type on the x-axis. There are three sets of bars, representing 0 months, 3 months, and 6 months. Each set has two bars, one for "Control" and one for "Control + SRT", with corresponding values of 1524.50 and 662.56 for 0 months, 1147.63 and 3043.43 for 3 months, and 723.74 and 2862.94 for 6 months. The pullout force increases with the addition of SRT.

Figure 6: Screw pullout force test results. For this test, the OGmend® Implant System is labeled as "-Control + SRT". The +Control and -Control groups represent the positive and negative controls described above.

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- Insertion Torque at the time of implantation, to validate bench models so as to ensure the ● sleeve does not excessively increase the torque needed in implant screws.
Image /page/10/Figure/1 description: This bar graph shows the in vivo insertion torque for different treatments. The x-axis represents the treatment type, and the y-axis represents the torque in Newton-meters. The positive control has a torque of 1.15 N-m, the negative control has a torque of 0.06 N-m, and the negative control with SRT treatment has a torque of 0.96 N-m.

Figure 7: Insertion Torque results, measured at baseline

- Extraction Torque at each time point, to assess the stability of the implant over time ● compared to controls.
Image /page/10/Figure/4 description: The image is a bar graph titled "Screw Break Out Torque". The x-axis is labeled "Treatment Type" and has three categories: 0 Months, 3 Months, and 6 Months. The y-axis is labeled "Break Out Torque (N-m)" and ranges from -16 to 0. For each treatment type, there are three bars representing different control conditions: +Control, -Control, and +SRT. At 0 months, the +Control bar is at -7.24, the -Control bar is at -0.31, and the +SRT bar is at -7.85. At 6 months, the +Control bar is at -11.05, the -Control bar is at -1.29, and the +SRT bar is at -11.90.

Figure 8: Extraction Torque results, measured at each time point

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- Pullout Stiffness was measured at each time point, to assess the mechanical stability of . the implant compared to controls.
Image /page/11/Figure/1 description: The image is a bar graph titled "Screw Pullout Stiffness" that compares the screw pullout stiffness (N/mm) of different treatment types over 0, 3, and 6 months. The x-axis represents the treatment type, which includes control and control + SRT, while the y-axis represents the screw pullout stiffness in N/mm, ranging from 0 to 800. At 0 months, the control group has a stiffness of 432.47, while the control + SRT group has a stiffness of 436.91. At 6 months, the control group has a stiffness of 567.36, while the control + SRT group has a stiffness of 501.00.

Figure 9: Pullout Stiffness data at each timepoint

- Kinematics of the fusion site to demonstrate that the device provided sufficient stability ● to allow for clinically relevant healing of the fusion site, as an analog for fusion of a fracture. Assessment included range of motion and bending stiffness in Flexion/Extension, Lateral bending, and Axial Rotation.
Image /page/11/Figure/4 description: The image contains two bar charts comparing the lateral bending range of motion and stiffness with and without rods over 0, 3, and 6 months. The left chart shows the range of motion in degrees, with values of 11.35, 9.39, and 10.62 at 0 months, decreasing to 1.22, 2.65, and 1.01 at 3 months, and further decreasing to 0.21, 0.20, and 0.19 at 6 months. The right chart shows stiffness in N-m/Deg, with values of 0.86, 1.25, and 0.84 at 0 months, increasing to 13.55, 15.15, and 12.84 at 3 months, and further increasing to 57.33, 77.26, and 71.40 at 6 months.

Figure 10: Lateral Bending Range of Motion, and Lateral Bending Stiffness results

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- Histological, Histopathological, and Histromorphometric assessment of the tissue around ● the implant at each time point. This data was analyzed to determine if the implant or wear particles generated by the implant resulted in a negative biologic reaction which may be detrimental to the long-term health of the tissue.
Image /page/12/Picture/1 description: The image shows a close-up of a textile material with a repeating pattern. The pattern consists of rounded shapes, possibly representing loops or knots, arranged in rows. The colors are predominantly red and white, with some darker areas that could be shadows or variations in the material. The overall impression is of a textured surface with a complex, interwoven structure.

Figure 11: Example histology image of screw and OGmend® Implant System in the Ovine Spine at 24 weeks. Image above shows the bone screw (black) imbedded in bone (stained red). The OGmend® Implant System can be seen as the colorless fibers around the screw (black arrows).

Image /page/12/Figure/3 description: The image is a bar graph titled "Average Radiographic Scores". The x-axis shows three groups labeled Group 1, Group 2, and Group 3. The y-axis shows the average radiographic scores from 0 to 4. For each group, there are two bars, one representing the bridging score and the other representing the new bone formation score. The bridging scores for each group are around 1, while the new bone formation scores are around 3.

- Radiographic review of the fusion site to confirm that fusion occurred.
Figure 12: Results of radiographic assessment. Bridging score was an assessment of the percentage of bone bridge formed across the fusion site, with a score of 1 indicating the highest bridging (76-100%). Group 1 represents the Positive Control group, Group 2 represent the Negative Control group, and Group 3 represents the Treatment group (Negative Control plus the OGmend Implant System). New bone formation score was an assessment of bone formed, with a score of 4 representing the best score. There was no significant difference observed between groups.

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Overall, it was determined that the data provided were sufficient to demonstrate that the device provided sufficient mechanical stability for healing, and that the observed biologic response at 12 and 24 weeks was not significant enough to cause long term adverse biological reaction.

# LABELING

The safety and effectiveness of the device was evaluated with respect to the use with metallic plate and screw systems in long bones, and was not evaluated in conditions in which the sleeve crossed a fracture site. To clarify the use of the device with respect to the supporting data provided to demonstrate safety and effectiveness, the device labeling was revised to including the following:

- The device description states the material used for the implant (PET). ●
- The Indications for Use statement states the device is for use in skeletally mature ● patients.
- The device is contraindicated for patients with insufficient bone quality or quantity to permit stabilization of a plate and screw system.
- There is a warning that the device should not be used in stand-alone screw systems, joint arthroplasty systems, and spinal fixation procedures.
- . There is a warning that the device should not be used with non-metallic or resorbable screws.
- . While the material of the device is a pure polymer and contains no metallic components, and there are no safety concerns regarding the presence of the sleeve in a Magnetic Resonance (MR) environment, it is only intended to be used with metallic bone screws. and therefore the labeling includes precautions that the MR safety of the plates and screws should be considered.

# RISKS TO HEALTH

The table below identifies the risks to health that may be associated with the use of a screw sleeve bone fixation device and the measures necessary to mitigate these risks.

| Identified Risks to Health | Mitigation Measures |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Loss of function / mechanical integrity<br>resulting from:<br>• Device malposition<br>• Device breakage<br>• Damage to screw during insertion<br>• Deterioration due to aging<br>• Insufficient restoration of screw fixation | In vivo performance testing<br>Non-clinical performance testing<br>Shelf life testing<br>Labeling |
| Revision | In vivo performance testing<br>Non-clinical performance testing<br>Labeling |
| Adverse tissue reaction | Biocompatibility evaluation |

# Table 4: Identified Risks to Health and Mitigation Measures

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| | <i>In vivo</i> performance testing<br>Non-clinical performance testing<br>Labeling |
|------------------------------------|------------------------------------------------------------------------------------|
| Infection | Sterilization validation<br>Shelf life testing |
| Febrile response due to endotoxins | Pyrogenicity testing |

# SPECIAL CONTROLS

In combination with the general controls of the FD&C Act, the screw sleeve bone fixation device is subject to the following special controls:

- In vivo performance testing under anticipated conditions of use must demonstrate: (1)
- The device provides sufficient stability to allow for fracture healing; and (i)
- (ii) A lack of adverse biologic response to the implant through histopathological and histomorphometric assessment.
- (2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must:
- Assess the stability of the device in a rescue screw scenario; (i)
- Demonstrate that the device can be inserted and removed without damage to (ii) the implant or associated hardware;
- Demonstrate the device can withstand dynamic loading without device failure; (iii) and
- (iv) Characterize wear particle generation.
- The device must be demonstrated to be biocompatible. (3)
- The device must be demonstrated to be non-pyrogenic. (4)
- Performance data must demonstrate the sterility of the device. (ર)
- Performance data must support the labeled shelf life of the device by demonstrating (6) continued sterility, package integrity, and device functionality over the established shelf life.
- (7) Labeling must include:
- A detailed summary of the device technical parameters; (i)
- Information describing all materials of the device; (ii)
- Instructions for use, including device removal; and (iii)
- (iv) A shelf life.

# BENEFIT-RISK DETERMINATION

The sponsor has collected adequate data to assess the safety profile of the subject device and has identified that there are benefits. The known or probable risks of the device include biologic responses to polymeric surgical implants, specifically polyethylene terephthalate implants, documented in the published literature or observed in the animal studies conducted for this device, as well as mechanical failure modes either anticipated or observed in the mechanical testing of the device as described above. While there was an ongoing foreign body reaction at the

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final time point in the animal spine model study, it was determined that the degree of reaction would not lead to unacceptable risk to patients.

## Patient Perspectives

This submission did not include specific information on patient perspectives for this device. Benefit/Risk Conclusion

In conclusion, given the available information above, the data support that for the following indications for use statement:

The OGmend® Implant System is intended for use with screws as part of a fracture fixation plate system in long bones in rescue scenarios where the screw has lost purchase due to screw loosening, back out, or breakage and the stability of the overall construct is at risk. The OGmend® Implant System is for use in skeletally mature patients.

the probable benefits outweigh the probable risks for the OGmend® Implant System. The device provides benefits, and the risks can be mitigated by the use of general controls and the identified special controls.

## CONCLUSION

The De Novo request for the OGmend® Implant System is granted and the device is classified as follows:

Product Code: QAC Device Type: Screw sleeve bone fixation device Regulation Number: 21 CFR 888.3043 Class: II