(505 days)
Not Found
Not Found
No
The device description and performance studies focus on the mechanical properties and biological response to a physical implant, with no mention of software, algorithms, or data processing related to AI/ML.
Yes
The device aids in fracture fixation, which is a therapeutic intervention to promote bone healing.
No
The device is an implant system designed to provide supplemental fixation for fracture repair, not to diagnose a condition.
No
The device description clearly states it is a sterile, single-use device manufactured from woven polyethylene terephthalate (PET) and is intended to be physically inserted into bone. This indicates it is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the mechanical fixation of bone fractures in rescue scenarios where existing screws have failed. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The device is a physical implant designed to provide mechanical stability to a bone-plate construct. It does not analyze biological samples (blood, tissue, etc.) to provide diagnostic information.
- Performance Studies: The performance studies focus on mechanical properties (pullout strength, torque, stiffness, durability) and biological response to the implant in animal models. There are no studies related to diagnostic accuracy (sensitivity, specificity, etc.).
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing information about a patient's health status or disease.
In summary, the OGmend® Implant System is a medical device used for surgical intervention and mechanical support, not for performing in vitro diagnostic tests.
N/A
Intended Use / 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.
Product codes
QAC
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.
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 System, in order to generate mechanical interferences and improve the stability of the screw and bone-plate construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Long bones
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
PERFORMANCE TESTING - BENCH
-
Screw Axial Pullout
- Purpose: This test is intended to assess if the subject device provides improved stability compared to an alternate treatment for a failed screw.
- Method: To simulate a rescue scenario, a 3.5 mm pilot hole was made in 20 pcf Sawbone. The device was then implanted in combination with a 3.5 mm screw. The screw was then pulled axially until failure as per ASTM F543. 4.0 mm screws were inserted into 3.5 mm pilot holes to simulate placing a larger screw in a failed screw hole as a control.
- Results: Test results show that the force required to pull out a 3.5 mm screw with the OGmend® Implant System in place exceeded the force required to pull out a 4.0 mm screw without the OGmend® Implant System. The acceptance criteria were met.
-
Sleeve Dynamic Axial Loading, Pullout and Removal/Extraction Torque
- Purpose: This test is intended to assess if dynamic loading would damage the implant and/or cause a reduction in pullout strength.
- Method: A control group (without the OGmend® Implant System) and treatment group (with the OGmend® Implant System) were defined. Axial loading is considered to constitute the worst-case clinical loading scenario as compression plates are designed to generate axial loading on the screw, and the resultant force on the screw would be reduced by transfer of some load to the plate. Each screw was sinusoidally loaded between N and % of the pullout force determined from static testing for a total of cycles at a rate of Hz. For reference, the pullout force was re-evaluated during this testing to determine the correct % value. The % pullout force value for the subject device was N and was N for the control. At the completion of cycles, removal torque and pullout testing were conducted per ASTM F543.
- Results: The test results showed no decrease in axial pullout force or removal torque in either the control group or in the OGmend® Implant System treatment group. This testing demonstrated that cyclic loading did not negatively affect the mechanical strength of the device or the stability of the interference fit.
-
Sleeve Insertion Force
- Purpose: This test is intended to evaluate the force required to insert the sleeve compared to the force required to insert the sleeve manually during a surgical procedure.
- Method: The axial force needed to push the sleeve into a pilot hole using an inserter tool in pcf bone foam was measured. Testing was performed with both a 3.5 mm and 6.5 mm pilot hole to represent the smallest and largest potential holes compatible with the device. To assess the load needed to cause damage to the sleeve, a probe was pressed through the sleeve against the distal tip at a constant rate until failure of the sleeve occurred.
- Results: For both a 3.5 mm and a 6.5 mm pilot hole, it required less than N to insert the device (N in the 3.5 mm hole, and N in the 6.5 mm hole). This compares to an average force of 0.1 N needed to rupture the distal end of the sleeve. This demonstrated that the device can be successfully inserted into bone using the provided surgical technique and instruments without damage to the device.
-
Screw Removal/Extraction Torque
- Purpose: This test is intended to assess the ability of the screw to be inserted and extracted when used with the OGmend® Implant System compared to a traditional, fully threaded bone screw OGmend® Implant System. The intent of the test is to demonstrate that the interference generated by the implant did not increase the insertion/removal torque sufficiently breakage of the screw during implantation or removal, or not allow for proper implantation of the screw.
- Method: The investigational cohort, consisting of the OGmend® Implant System and screw, was tested with two screw diameters (3.5mm and 6.5mm) in 20 pcf sawbone. Pilot holes were made in the sawbone, and the sleeve and screw were implanted following the surgical technique. During insertion, torque was insertion, the screw was then removed while measuring torque, as per ASTM F543-17. The torsional strength of the screw was assessed by torqueing the screw until failure as per ASTM F543.
- Results: The OGmend® Implant System did increase the torque needed to insert and remove the screw. The torque to insert the screw increased from 0.025 Nm to 0.133 Nm (3.5 mm) and from 0.123 Nm to 0.651 Nm (6.5 mm screw). Similarly, the torque to extract the screw increased from 0.025 Nm to 0.180 Nm (3.5 mm) and from 0.137 to 0.803 Nm (6.5 mm screws). While there was an increase in the torque required to implant and remove the screw, the torque was still significantly less than the yield torque of the screws being tested, indicating there is no risk of screw failure during insertion and removal.
-
Durability of Sleeve during Screw Implantation
- Purpose: This test is intended to assess if the OGmend® Implant System can be inserted into the bone without damage of the device, using the provided instruments, in preparation for the placement of a screw.
- Results: Testing showed no reduction in pullout strength of a screw compared to baseline. This indicates the device can withstand the handling of surgery without damage that could affect its mechanical performance.
-
Wear Particle Generation
- Purpose: This test is intended to assess if the sleeve can withstand screw insertion and cyclic loading without damage. There is potential for the screw threads to generate wear particles during insertion, or during toggling during cyclic loading.
- Method: layer was used. The device was implanted following the surgical technique, and a 325 N load was applied at R = 10 at 5 Hz for 1 million cycles. Following testing, the test block and specimens were assessed for particulate generation, and high-resolution photographs of the sleeve were taken to assess if damage occurred to the device.
- Results: Assessment of images found no significant damage occurred to the structural integrity of the device. A total particulate measure of 0.12 = 0.24 (range 0.005 to 0.661) mg of PET was recorded in the dynamically loaded samples, compared to 0.21 = 0.23 (range 0.026 to 0.654) in the control group. Total particle count was different between groups, with an average of 3.26E4 ± 2.70E4 particles in the toggle group and 1.26E6 ± 1.64E6 in the control group.
PERFORMANCE TESTING - ANIMAL AND/OR CADAVER
- Spine Model Study
- Study Type: In vivo animal study
- Sample Size: 54 Animals (18 per group for Positive Control, Negative Control, Treatment)
- Data Source: Sheep lumbar spine to evaluate vertebral pedicle screw fixation for spinal fusion.
- Key Results: Data from the pivotal spine study was used in the final safety and efficacy determination.
- Axial Pullout force: Assessed fixation strength. The OGmend® Implant System (+SRT) showed an increase in pullout force over time compared to controls, with results of 2862.94N at 6 months compared to 723.74N for the control.
- Insertion Torque: Assessed that the sleeve does not excessively increase the torque needed. Negative control with SRT treatment had a torque of 0.96 N-m, close to the positive control (1.15 N-m), and much higher than the negative control (0.06 N-m).
- Extraction Torque: Assessed implant stability over time. At 6 months, +SRT showed -11.90 N-m, comparable to +Control (-11.05 N-m) and significantly better than -Control (-1.29 N-m).
- Pullout Stiffness: Assessed mechanical stability. At 6 months, control + SRT group had a stiffness of 501.00 N/mm.
- Kinematics of the fusion site: Demonstrated sufficient stability for healing. Lateral Bending Range of Motion decreased significantly for all groups from 0 to 6 months, and stiffness increased, indicating stability.
- Histological, Histopathological, and Histromorphometric assessment: Assessed tissue reaction. The observed biologic response at 12 and 24 weeks was not significant enough to cause long term adverse biological reaction.
- Radiographic review: Confirmed fusion occurred. No significant difference was observed between groups in average radiographic scores for bridging and new bone formation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Mechanical parameters are reported as force, torque, stiffness, and wear particulate generation.
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3043 Screw sleeve bone fixation device.
(a)
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.(b)
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.
0
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.
1
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
2
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
Contact | Contact Duration |
|---------------------------|----------------------------|---------------------------|------------------|
| OGmend®
Implant System | Polyethylene Terephthalate | Yes | (b)(4) |
| Inserter
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 | ||
| Reactivity | Yes | Yes |
| Acute Systemic Toxicity | Yes | Yes |
| Material-Mediated | ||
| Pyrogenicity | Yes | Yes |
3
| Subacute / Subchronic
| 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
4
- 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 | ||||
| Pullout | This test is intended | |||
| to assess if the | ||||
| subject device | ||||
| provides improved | ||||
| stability compared | ||||
| to an alternate | ||||
| treatment for a | ||||
| failed screw. | To simulate a rescue scenario, a | |||
| 3.5 mm pilot hole was made in 20 | ||||
| pcf Sawbone. The device was | ||||
| then implanted in combination | ||||
| with a 3.5 mm screw. The screw | ||||
| was then pulled axially until | ||||
| failure as per ASTM F543. 4.0 | ||||
| mm screws were inserted into 3.5 | ||||
| mm pilot holes to simulate | ||||
| placing a larger screw in a failed | ||||
| screw hole as a control. | The axial pullout | |||
| force of the screw in | ||||
| combination with the | ||||
| sleeve must be | ||||
| equivalent to or | ||||
| greater than the | ||||
| pullout force for a | ||||
| rescue screw alone. | Test results show | |||
| that the force | ||||
| required to pull | ||||
| out a 3.5 mm | ||||
| screw with the | ||||
| OGmend® | ||||
| Implant System | ||||
| in place exceeded | ||||
| the force required | ||||
| to pull out a 4.0 | ||||
| mm screw | ||||
| without the | ||||
| OGmend® | ||||
| Implant System. | ||||
| The acceptance | ||||
| criteria were met. | ||||
| Test | Purpose | Method | Acceptance Criteria | Results |
| (b) (4) | ||||
| Figure 3: Test setup for Axial | ||||
| Pullout | ||||
| Sleeve Dynamic | ||||
| Axial Loading, | ||||
| Pullout and | ||||
| Removal/ | ||||
| Extraction | ||||
| Torque | This test is intended | |||
| to assess if dynamic | ||||
| loading would | ||||
| damage the implant | ||||
| and/or cause a | ||||
| reduction in pullout | ||||
| strength. | A control group (without the | |||
| OGmend® Implant System) and | ||||
| treatment group (with the | ||||
| OGmend® Implant System) were | ||||
| defined. (b) (4) |
Axial loading is considered to
constitute the worst-case clinical
loading scenario as compression
plates are designed to generate
axial loading on the screw, and
the resultant force on the screw
would be reduced by transfer of
some load to the plate.
Each screw was sinusoidally
loaded between $(b)$ N and $(b)$ % of
the pullout force determined from | After (b) (4) cycles,
there should be no
decrease in pullout
values or damage to
the device. | The test results
showed no
decrease in axial
pullout force or
removal torque in
either the control
group or in the
OGmend®
Implant System
treatment group.
This testing
demonstrated
that cyclic
loading did not
negatively affect
the mechanical
strength of the
device or the
stability of the
interference fit. |
| Test | Purpose | Method | Acceptance Criteria | Results |
| | | static testing for a total of (b) (4)
cycles at a rate of Hz. For
reference, the pullout force was
re-evaluated during this testing to
determine the correct (b)% value.
The (b)% pullout force value for
the subject device was (b) N and
was (b) N for the control.
At the completion of(b) (4)
cycles, removal torque and
pullout testing were conducted
per ASTM F543. | | |
| Sleeve Insertion
Force | This test is intended
to evaluate the force
required to insert the
sleeve compared to
the force required to
insert the sleeve
manually during a
surgical procedure. | The axial force needed to push
the sleeve into a pilot hole using
an inserter tool in (b) pcf bone
foam was measured. Testing was
performed with both a 3.5 mm
and 6.5 mm pilot hole to represent
the smallest and largest potential
holes compatible with the device.
To assess the load needed to
cause damage to the sleeve, a
probe was pressed through the
sleeve against the distal tip at a
constant rate until failure of the
sleeve occurred.
(b) (4)
Figure 4: Test setup for sleeve
mechanical strength test | No more than(b) N
should be required to
insert the OGmend®
Implant System. This
was based on an
assessment of load
needed to damage the
device with a margin
of safety. | For both a 3.5
mm and a 6.5
mm pilot hole, it
required less than
(b) N to insert the
device (b) (4)
N in the 3.5 mm
hole, and(b) (4)
N in the 6.5 mm
hole). This
compares to an
average force of
(b) .1 N needed
to rupture the
distal end of the
sleeve.
This
demonstrated
that the device
can be
successfully
inserted into
bone using the
provided surgical
technique and
instruments
without damage
to the device. |
| Screw Removal/
Extraction
Torque | This test is intended
to assess the ability
of the screw to be
inserted and
extracted when used
with the OGmend®
Implant System
compared to a
traditional, fully
threaded bone screw | The investigational cohort,
consisting of the OGmend®
Implant System and screw, was
tested with two screw diameters
(3.5mm and 6.5mm) in 20 pcf
sawbone. Pilot holes were made
in the sawbone, and the sleeve
and screw were implanted
following the surgical technique.
During insertion, torque was | The torque required
to insert and remove
the screw with the
OGmend® Implant
System in place must
be less than the
torsional strength of
the screw | The OGmend®
Implant System
did increase the
torque needed to
insert and
remove the
screw. The
torque to insert
the screw
increased from
0.025 Nm to |
| Test | Purpose | Method | Acceptance Criteria | Results |
| | OGmend® Implant
System. The intent
of the test is to
demonstrate that the
interference
generated by the
implant did not
increase the
insertion/removal
torque sufficientlybreakage of the
screw during
implantation or
removal, or not
allow for proper
implantation of the
screw. | insertion, the screw was then
removed while measuring torque,
as per ASTM F543-17.
The torsional strength of the
screw was assessed by torqueing
the screw until failure as per
ASTM F543.
(b) (4)
Image: Figure 5: Test setup for insertion torque testing. | | 0.133 Nm (3.5
mm) and from
0.123 Nm to
0.651 Nm (6.5
mm screw).
Similarly, the
torque to extract
the screw
increased from
0.025 Nm to
0.180 Nm (3.5
mm) and from
0.137 to 0.803
Nm (6.5 mm
screws)
While there was
an increase in the
torque required
to implant and
remove the
screw, the torque
was still
significantly less
than the yield
torque of the
screws being
tested, indicating
there is no risk of
screw failure
during insertion
and removal. |
| Durability of
Sleeve during
Screw
Implantation | This test is intended
to assess if the
OGmend® Implant
System can be
inserted into the
bone without
damage of the
device, using the
provided
instruments, in
preparation for the
placement of a
screw. | (b) (4) | Screw pullout force
following repeated
insertions must not be
reduced compared to
prior axial pullout
testing. | Testing showed
no reduction in
pullout strength
of a screw
compared to
baseline. This
indicates the
device can
withstand the
handling of
surgery without
damage that
could affect its
mechanical
performance. |
| Wear Particle
Generation | This test is intended
to assess if the
sleeve can withstand
screw insertion and
cyclic loading | (b) (4) | The device should
not sustain damage
such that it fails to
perform its intended
function, and wear | Assessment of
images found no
significant
damage occurred
to the structural |
| Test | Purpose | Method | Acceptance Criteria | Results |
| | without damage.
There is potential
for the screw threads
to generate wear
particles during
insertion, or during
toggling during
cyclic loading. | layer was used. The device was
implanted following the surgical
technique, and a 325 N load was
applied at R = 10 at 5 Hz for 1
million cycles. Following testing,
the test block and specimens were
assessed for particulate
generation, and high-resolution
photographs of the sleeve were
taken to assess if damage
occurred to the device. | particles generated
should be fully
characterized. | integrity of the
device.
A total
particulate
measure of 0.12
$\pm$ 0.24 (range
0.005 to 0.661)
mg of PET was
recorded in the
dynamically
loaded samples,
compared to 0.21
$\pm$ 0.23 (range
0.026 to 0.654)
in the control
group. Total
particle count
was different
between groups,
with an average
of 3.26E4 $\pm$
2.70E4 particles
in the toggle
group and
1.26E6 $\pm$ 1.64E6
in the control
group. |
Table 3: Summarv of Bench Testing
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6
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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 | ||
| with Osteotomy | Ovine Metatarsal | |||
| with Osteotomy | Ovine Lumbar | |||
| Spine Fusion | ||||
| Sample Size | 10 Animals | 4 Animals | 18 Animals + 6 | |
| Cadaveric | 54 Animals | |||
| Construct | Screw only (6 | |||
| Cortical and 2 | ||||
| Cancellous screws | ||||
| per animal) | 9-Hole Plate (7 | |||
| Cortical and 2 | ||||
| Cancellous screws | ||||
| per plate) | 9-Hole Plate (7 | |||
| Cortical and 2 | ||||
| Cancellous screws | ||||
| per plate) | L2-L3 Fusion (4 | |||
| pedicle screws and | ||||
| 2 rods) |
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| Screw Model | Osteotomy Model | Osteotomy Model | Spine Model | |
|---|---|---|---|---|
| Cohorts | Control: Bone | |||
| Screw (n=5) | ||||
| Treatment: Screws | ||||
| with OGmend® | ||||
| Implant System | ||||
| (n=5) | Control: Plate and | |||
| Screw Alone (n=2) | ||||
| Treatment: Plate | ||||
| and Screw with | ||||
| OGmend® Implant | ||||
| System (n=2) | Control: Cadaveric | |||
| Sheep (n=6) | ||||
| Treatment: Plate | ||||
| and Screw with | ||||
| OGmend® Implant | ||||
| System(n=18) | Positive Control (n | |||
| = 18) | ||||
| Negative Control | ||||
| (n=18) | ||||
| Treatment | ||||
| (Negative Control | ||||
| with OGmend® | ||||
| Implant System, n= |
- |
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 | |
| resulting from: | |
| • Device malposition | |
| • Device breakage | |
| • Damage to screw during insertion | |
| • Deterioration due to aging | |
| • Insufficient restoration of screw fixation | In vivo performance testing |
| Non-clinical performance testing | |
| Shelf life testing | |
| Labeling | |
| Revision | In vivo performance testing |
| Non-clinical performance testing | |
| Labeling | |
| Adverse tissue reaction | Biocompatibility evaluation |
Table 4: Identified Risks to Health and Mitigation Measures
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| | In vivo performance testing
Non-clinical performance testing
Labeling |
|------------------------------------|------------------------------------------------------------------------------------|
| Infection | Sterilization validation
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
15
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