(329 days)
QJD
Not Found
No
The summary describes a physical medical device (an absorbable bone screw) and its mechanical and clinical performance. There is no mention of software, algorithms, or any function that would typically involve AI or ML.
Yes
The device is described as an implant used for the fixation of bone fractures and osteotomies in traumatic and orthopedic surgery, which directly addresses a medical condition (fractures, malalignments) and supports healing, classifying it as a therapeutic device.
No
This device is a bone fixation fastener used in orthopedic surgery to fix fractures and osteotomies; it is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is an "absorbable metallic bone fixation fastener" manufactured from a magnesium-based alloy, which is a physical implant, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the RemeOs™ Screw LAG Solid is for the fixation of bone fractures and osteotomies in traumatic and orthopedic surgery. This is a direct surgical intervention on the body.
- Device Description: The device is a metallic bone fixation fastener that is implanted into the bone.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices that are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
The RemeOs™ Screw LAG Solid is an implantable surgical device used for mechanical support and fixation within the body, not for testing samples outside the body.
N/A
Intended Use / Indications for Use
RemeOs™ Screw LAG Solid is intended for the use in traumatic and orthopedic surgery for the fixation of bone fractures (osteosynthesis) and for the fixation after osteotomies, e.g., for the correction of deformities or malalignments. The absorbable implants serve as temporary fixation and stabilization by osteosynthesis of bone fractures and osteotomies until bony fusion has occurred.
The RemeOs™ Screw LAG Solid is intended to be used for skeletally mature adults.
The RemeOs™ Screw LAG Solid is indicated for the fixation of the medial malleolus.
Product codes
QJD
Device Description
The RemeOs™ Screw LAG Solid is an absorbable metallic bone fixation fastener. The product is manufactured from an absorbable magnesium-based alloy containing magnesium, zinc (0.55% (w/w)) and calcium (0.45% (w/w)). The material corrodes under physiological conditions into magnesium, calcium and zinc oxides and hydroxides, while producing hydrogen gas as byproduct. The implant serves as temporary fixation and stabilization by osteosynthesis of bones and fragments until bonv fusion has occurred.
The RemeOs™ Screw LAG Solid is provided in one design (Figure 1). The RemeOs™ Screw LAG Solid is a partially threaded solid headed screw with a diameter of 3.5 mm and is offered from lengths 24 to 40 mm in 2 mm increments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Image Artifact as per ASTM F2119-07 (2013), "Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants".
computed tomography (CT) scans; Serial radiographs
Anatomical Site
bone fractures (osteosynthesis), medial malleolus, osteotomies, medial talus ridge
Indicated Patient Age Range
skeletally mature adults
Intended User / Care Setting
traumatic and orthopedic surgery
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)
Summary of Nonclinical/Bench Studies:
- Biocompatibility/Materials: Biocompatibility evaluation was completed according to 2020 FDA Guidance, Use of International Standard ISO 10993-1. Tested successfully for Cytotoxicity, Sensitization, Irritation, Implantation Effects, Material Mediated Pyrogenicity, Acute/Subacute/Subchronic/Chronic Systemic Toxicity, Genotoxicity and Carcinogenicity. Results were deemed acceptable.
- Packaging, Sterilization, and Shelf Life:
- Sterility: Sterilization method (Dry Heat) validated in accordance with ISO 20857 to ensure a minimum sterility assurance level (SAL) of 10-9.
- Packaging and Shelf-Life: Accelerated and real time aging supported a 12-month shelf-life according to ASTM F1980. Package performance and integrity tested per ISO 11607 and ASTM D4169.
- Magnetic Resonance (MR) Compatibility: Tested for Magnetically Induced Displacement Force (ASTM F2052-15), Magnetically Induced Torque (ASTM F2213-17), Radiofrequency Induced Heating (ASTM F2182-19e), and Image Artifact (ASTM F2119-07).
- Results: Translational attraction of 1.53 Tesla, spatial gradient magnetic field of 466 gauss/cm, no torque. Maximum image artifact (gradient echo pulse sequence in 3.0 T MR scanner) extends linear distance of 5 mm relative to screw size. Maximum temperature rise after 60 minutes continuous exposure less than 6°C at SAR of 2 W/kg.
- Performance Testing – Bench (Mechanical Performance Evaluations):
- Torsional Testing: Evaluated maximum torsional strength. Method: ASTM F543-17. Performance Criteria: Statistically equivalent or greater to comparator device (absorbable polymer bone screws). Results: All specimens exceeded performance criteria.
- Axial Pullout Testing: Measured axial tensile force to fail/remove screw. Method: ASTM F543-17. Performance Criteria: Statistically equivalent or greater to comparator device (absorbable polymer bone screws). Results: All specimens exceeded performance criteria.
- Driving Torque Testing: Measured torque to drive screw. Method: ASTM F543-17. Performance Criteria: Max insertion torque
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR REMEOS™ SCREW LAG SOLID
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Absorbable metallic bone fixation fastener. An absorbable metallic bone fixation device is an implant, such as a bone screw, pin, or Kirschner wire, composed of one or more absorbable metal or metal alloys and intended to provide rigid bone fixation suitable for osteosynthesis. The device is designed to fully absorb after osteosynthesis is achieved.
NEW REGULATION NUMBER: 21 CFR 888.3041
CLASSIFICATION: Class II
PRODUCT CODE: QJD
BACKGROUND
DEVICE NAME: RemeOs™ Screw LAG Solid
SUBMISSION NUMBER: DEN220030
DATE DE NOVO RECEIVED: May 4, 2022
SPONSOR INFORMATION:
Bioretec Ltd. Yrittäjänkulma 5 FI-33710 TAMPERE FINLAND
INDICATIONS FOR USE
RemeOs™ Screw LAG Solid is intended for the use in traumatic and orthopedic surgery for the fixation of bone fractures (osteosynthesis) and for the fixation after osteotomies, e.g., for the correction of deformities or malalignments. The absorbable implants serve as temporary fixation and stabilization by osteosynthesis of bone fractures and osteotomies until bony fusion has occurred.
The RemeOs™ Screw LAG Solid is intended to be used for skeletally mature adults.
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The RemeOs™ Screw LAG Solid is indicated for the fixation of the medial malleolus.
LIMITATIONS
The sale, distribution, and use of the RemeOs™ Screw LAG Solid is restricted to prescription use in accordance with 21 CFR 801.109.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The RemeOs™ Screw LAG Solid is an absorbable metallic bone fixation fastener. The product is manufactured from an absorbable magnesium-based alloy containing magnesium, zinc (0.55% (w/w)) and calcium (0.45% (w/w)). The material corrodes under physiological conditions into magnesium, calcium and zinc oxides and hydroxides, while producing hydrogen gas as byproduct. The implant serves as temporary fixation and stabilization by osteosynthesis of bones and fragments until bonv fusion has occurred.
The RemeOs™ Screw LAG Solid is provided in one design (Figure 1). The RemeOs™ Screw LAG Solid is a partially threaded solid headed screw with a diameter of 3.5 mm and is offered from lengths 24 to 40 mm in 2 mm increments.
Image /page/1/Picture/7 description: The image shows a close-up of a metal screw. The screw has a flat head with a slot for a screwdriver. The shaft of the screw is smooth for most of its length, but the end of the screw has threads. The screw appears to be made of a shiny metal, possibly steel or aluminum.
Figure 1: RemeOs™ Screw LAG Solid
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The RemeOs™ Screw LAG Solid is manufactured from the following patient-contacting material:
Table 1: Manufactured Materials of Patient-Contacting Device Components
| Description | Material | Direct Patient
Contact | Contact
Duration |
|-------------|-----------------|---------------------------|-------------------------|
| Implant | Magnesium-alloy | Yes | Permanent
(>30 days) |
Biocompatibility evaluation has been completed according to 2020 FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."
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For this permanent implant, the following table shows the biocompatibility testing that was performed and the results, which were deemed acceptable for a permanent implant in contact with bone/tissue.
| Table 2. Biocompatibility Testing Performed | |
|---|---|
| Test Description | Result |
| Cytotoxicity (per ISO 10993-5 (Biological | |
| evaluation of medical devices — Part 5: Tests for | |
| in vitro cytotoxicity)) | Non-cytotoxic |
| Sensitization (ISO 10993-10 (Biological evaluation | |
| of medical devices — Part 10: Tests for irritation | |
| and skin sensitization)) | Non-sensitizing |
| Irritation (per ISO 10993-10 (Biological evaluation | |
| of medical devices — Part 10: Tests for irritation | |
| and skin sensitization) | Non-irritant |
| Implantation Effects (per ISO 10993-6 (Biological | |
| evaluation of medical devices — Part 6: Tests for | |
| local effects after implantation)) | Null to minimal reactivity |
| Material Mediated Pyrogenicity (per ISO 10993-11 | |
| (Biological evaluation of medical devices — Part | |
| 11: Tests for systemic toxicity)) | Non-pyrogenic |
| Acute/Subacute/Subchronic/Chronic Systemic | |
| Toxicity, (addressed through animal testing | |
| (Biological evaluation of medical devices —Part | |
| 11:Tests for systemic toxicity) and chemical | |
| characterization and toxicological risk assessment | |
| per ISO 10993-18 (Biological evaluation of | |
| medical devices — Part 18: Chemical | |
| characterization of medical device materials within | |
| a risk management process)/ISO 10993-17 | |
| (Biological evaluation of medical devices — Part | |
| 17: Establishment of allowable limits for leachable | |
| substances)) | Does not elicit systemic toxicity |
| Genotoxicity and Carcinogenicity (addressed | |
| through chemical characterization and | |
| toxicological risk assessment per ISO 10993-18 | |
| (Biological evaluation of medical devices — Part | |
| 18: Chemical characterization of medical device | |
| materials within a risk management process)/ISO | |
| 10993-17 (Biological evaluation of medical | |
| devices — Part 17: Establishment of allowable | |
| limits for leachable substances) | Non-genotoxic/non-carcinogenic |
Table 2: Biocompatibility Testing Performed
PACKAGING, STERILIZATION, AND SHELF LIFE
Sterility
The RemeOs™ Screw LAG Solid is provided clean and sterile to the end-user.
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Sterilization method (Dry Heat) of the device has been validated in accordance with ISO 20857, "Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices" to ensure a minimum sterility assurance level (SAL) of 10-9.
Packaging and Shelf-Life
The product packaging consists of an inner protective barrier made of silicone and outer sterile barrier system (SBS) made of nylon, which is placed into a protective cardboard box. Package performance and package integrity testing were performed in accordance with FDA recognized standard ISO 11607.
Accelerated and real time aging of the dry-heat sterilized device to support a 12-month shelf-life were performed in accordance with ASTM F1980, "Standard Guide for Accelerated Aging of Sterile Medical Device Packages" and supported a 12-month shelflife. The expiration date of 12 months was verified by demonstrating package stability through visual inspection, seal width, dye penetration, and seal strength testing on the stored packaging.
Device packaging maintenance of sterility when subjected to the rigors of real-world shipping and handling was demonstrated by testing conducted in accordance with ASTM D4169, "Standard Practice for Performance Testing of Shipping Containers and Systems"
MAGNETIC RESONANCE (MR) COMPATIBILITY
To support MR conditional labeling for the RemeOs™ Screw LAG Solid implant, the following MR testing was conducted to evaluate device safety and compatibility:
- . Magnetically Induced Displacement Force per ASTM F2052-15, "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment";
- Magnetically Induced Torque per ASTM F2213-17, "Standard Test Method for ● Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment";
- Radiofrequency Induced Heating per ASTM F2182-19e, "Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging"; and
- Image Artifact as per ASTM F2119-07 (2013), "Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants".
In magnetic field interaction tests, the RemeOs™ Screw LAG Solid implant showed a translational attraction of 1.53 Tesla, the spatial gradient magnetic field was 466 gauss/cm and no torque. In image artifact testing, the maximum image artifact was
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measured for both spin echo and gradient echo pulse sequences in a 3.0 T MR scanner, and the maximum artifact size, on the gradient echo pulse sequence, extends a linear distance of 5 mm relative to the size and shape of the cannulated screw. In MRI-related heating testing, test results and in vivo modeling show that, the maximum temperature rise after 60 minutes continuous exposure is less than 6°C under the condition of the whole-body specific absorption rate (SAR) at 2 W/kg.
PERFORMANCE TESTING – BENCH
A summary of non-clinical mechanical performance evaluations is provided in Table 3:
| Test | Purpose | Method | Performance
Criteria | Results |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Torsional
Testing | The aim of this test
was to evaluate the
maximum torsional
strength of the
RemeOs™ Screw
LAG Solid prior to
degradation when
considering worst-
case screw
dimensions.
Absorbable
polymer bone
screws were used
as a comparator
device. | Testing was conducted in
accordance with ASTM
F543-17 (Standard
Specification and Test
Methods for Metallic
Medical Bone Screws). | The torsional
yield strength
should be
statistically
equivalent or
greater to that of
the comparator
device. | All specimens
exceeded the
performance
criteria. |
| Axial Pullout
Testing | The objective of
this test was to
measure the axial
tensile force
required to fail or
remove a bone
screw from a
defined material
prior to implant
degradation.
Absorbable
polymer bone
screws were used
as comparator
devices. | Testing was conducted in
accordance with ASTM
F543-17 (Standard
Specification and Test
Methods for Metallic
Medical Bone Screws). | The torsional
yield strength
should be
statistically
equivalent or
greater to that of
the comparator
device. | All specimens
exceeded the
performance
criteria. |
| Driving
Torque
Testing | The aim of this test
was to measure the
torque required to
drive a bone screw
into a standard | Testing was conducted in
accordance with ASTM
F543-17 (Standard
Specification and Test | The maximum
insertion torque in
the driving torque
test (ASTM F543-
17 Annex 2) must | All specimens met
the acceptance
criteria. |
| Test | Purpose | Method | Performance
Criteria | Results |
| | material prior to
degradation. | Methods for Metallic
Medical Bone Screws). | be statistically
equal to or less
than 80% of the
minimum
allowable yield
torque of the
corresponding
screw type in the
torsional strength
test to allow for
safe insertion. | |
| Mass Loss
Testing | The aim of this test
was to characterize
the in vitro
degradation profile
of the RemeOsTM
Screw LAG Solid
by evaluating mass
loss and
dimensional
measurements over
time. | In vitro degradation testing
was performed in
accordance with ASTM
F3268-18 (Standard Guide
for in vitro Degradation
Testing of Absorbable
Metals). Test specimens
(screws, rods, and discs)
were tested in solution or
mounted in artificial bone
blocks. | The test
specimens
degrade in a
controlled manner
achieving steady
or declining state
( in vitro mass loss
rate is steady or
decreasing) by the
end of the study
(i.e., 26 weeks). | All specimens met
the acceptance
criteria. The
results of this
study were used to
perform an in
vitro – in vivo
correlation
analysis. |
| Longitudinal
Flexural
Static Testing | The objective was
to study the in vitro
static bending
properties of the
RemeOsTM Screw
LAG Solid as the
product is degraded
in vitro .
Absorbable
polymer bone
screws were used
as comparator
devices. | In vitro degradation was
adapted from methods
described in ASTM F3268-
18 (Standard Guide for in
vitro Degradation Testing
of Absorbable Metals),
ASTM F1635-16 (Standard
Test Method for in vitro
Degradation Testing of
Hydrolytically Degradable
Polymer Resins and
Fabricated Forms for
Surgical Implants) and
ASTM D790-17 (Standard
Test Methods for Flexural
Properties of Unreinforced
and Reinforced Plastics and
Electrical Insulating
Materials). The in vitro
fatigue resistance to cyclic
bending forces of the
RemeOsTM Screw Lag Solid
material must be at least
statistically equivalent or
better compared to that of
the comparator device. | The in vitro
flexural fatigue
performance of
the RemeOsTM
Screw LAG Solid
test specimens
must be at least
statistically
equivalent or
better compared to
that of the
comparator device
after in vitro
degradation. | All specimens
exceeded the
performance
criteria. |
| Test | Purpose | Method | Performance
Criteria | Results |
| Longitudinal
Flexural
Fatigue
Testing | The aim of this
study was to
evaluate the fatigue
performance of the
RemeOs™ Screw
LAG Solid as the
product is degraded
in vitro .
Absorbable
polymer bone
screws were used
as a comparator
device. | In vitro degradation and
flexural fatigue testing were
adapted from methods
described in ASTM F3268-
18 (Standard Guide for in
vitro Degradation Testing
of Absorbable Metals),
ASTM F1635-16 (Standard
Test Method for in vitro
Degradation Testing of
Hydrolytically Degradable
Polymer Resins and
Fabricated Forms for
Surgical Implants) and
ASTM F1264-16 (Standard
Specification and Test
Methods for Intramedullary
Fixation Devices).
Cylindrical test rods were
used as representative test
specimens. Specimens were
degraded in vitro in
artificial bone blocks.
Fatigue performance was
evaluated at 0, 4, and 8
weeks of in vitro
degradation. | The in vitro
fatigue resistance
to cyclic bending
forces of the
RemeOs™ LAG
Solid test
specimen must be
at least
statistically
equivalent or
better compared to
that of the
comparator device
after in vitro
degradation. | All specimens
exceeded the
performance
criteria. |
| Longitudinal
Axial Pullout
Strength | The aim of this
study was to
evaluate the axial
pullout strength of
the RemeOs™
Screw LAG Solid
as the product is
degraded in vitro .
Absorbable
polymer bone
screws were used | In vitro degradation and
axial pullout testing were
adapted from methods
described in ASTM F3268-
18 (Standard Guide for in
vitro Degradation Testing
of Absorbable Metals),
ASTM F1635-16 (Standard
Test Method for in vitro
Degradation Testing of
Hydrolytically Degradable
Polymer Resins and | The axial pullout
strength of the
RemeOs™ test
specimen must be
statistically
equivalent or
greater to that of
the comparator
device after in
vitro degradation. | All specimens
exceeded the
performance
criteria. |
| Test | Purpose | Method | Performance
Criteria | Results |
| | as comparator
devices. | Fabricated Forms for
Surgical Implants) and
ASTM F543-17 (Standard
Specification and Test
Methods for Metallic
Medical Bone Screws).
Specimens were degraded
in vitro in artificial bone
blocks for up to 26 weeks. | | |
Table 3: Summary of Non-clinical Mechanical Performance Evaluations
5
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7
SUMMARY OF CLINICAL INFORMATION
The 'Clinical application of Magnesium (Mg)-based biodegradable material for fracture fixation in the adult skeleton - First in man study' (MGAS) enrolled otherwise healthy adults between 18 and 65 years of age presenting to a Level I outside the United States (OUS) trauma center with an unstable ankle injury that included a displaced medial malleolus fracture (displaced was defined as diastasis of the fracture in any direction of 2 mm or more).
All subjects underwent surgery during which the medial malleolus fracture was reduced and stabilized with either one (2 subjects) or two (18 subjects) ZX00 bioresorbable magnesium screws (3.5 x 40mm solid LAG; scientifically denoted as ZX00 and marketed as RemeOs™ Screw LAG Solid). Associated fractures, such as of the fibula, were treated with conventional titanium screws and plates. Outcomes were assessed by clinical (physical examination, talocrural motion, pain visual analogue scale (VAS), and American Orthopaedic Foot & Ankle Society (AOFAS) scores), laboratory (serum Mg2+, Zn2+, and Ca2+ concentrations, renal function) and radiographic evaluations performed at approximately 2, 6, 12, 24, 52, 104, and 130 weeks after surgery. All subjects were followed for close to 130 weeks (2.5 years) with the exception of one subject, who was healed at 12 weeks, but was subsequently lost to follow-up.
Clinical and radiographic healing of 90% of subjects (18 patients) occurred within 6 weeks with stable consolidation observed for the remaining 2 subjects at the 12 weeks follow-up appointment. Differences in the talocrural joint range of motion (dorsal flexion/plantar flexion) between the operated site and the contralateral non-operated side averaged 39° ± 12° after 2 weeks and declined to 2° ± 11° by 1 year. VAS scores averaged 1.6 ± 0.6 points after surgery, 1.3 ± 0.5 points after 2 weeks, and 1.0 (no medial malleolus pain) thereafter. At the 52-week follow-up examination, the AOFAS score was 90.8 ± 7.1 points and improved to 93.7 ± 5.2 by 130 weeks.
The MGAS investigators reported 12 mild to moderate non-serious adverse events (AEs) during an average subject follow-up of 2.5 years. These self-limited, likely non-device-related, AEs included mild post-operative discomfort (8 subjects), knee pain (1 subject), mild localized swelling (1 subject) and moderate self-limited pain of unknown origin (2 subjects). Two likely non-device-related serious adverse events were also reported. One subject experienced a pulmonary embolism, and a second subject underwent an additional surgery, an osteochondral
8
autograft transfer system (OATS) procedure 1 year post-injury to treat a persistent osteochondral defect of the medial talus ridge.
Although all fractures clinically and radiographically healed within 12 weeks of surgery, serial radiographs displayed radiolucent zones localized around the screws, attributed to absorption byproducts (i.e., hydrogen gas). In general, the radiolucencies increased up to post-operative week 6, remained constant until week 12, and then decreased. After 2.5 years (130 weeks average) bone loss was still visible on computed tomography (CT) scans; however, new bone formation was extensive. No refractures or new bone fractures were reported. Residual screw volume (y), as estimated from subject CT scans, linearly declined over time (x weeks) and approached 0 (full absorption) at 149 weeks (y = -1.4664x + 218.02 R2 = 0.976). Serum concentrations of Mg2+ and Ca2+ and estimated renal function remained within normal physiological limits throughout the study.
Subject Demographics
A total of 20 patients were enrolled in the MGAS clinical study trial. Subjects' mean age and standard deviation was 40.1 ± 14.5 years. 11 subjects were male, and 9 subjects were female with an average Body Mass Index (BMI) of 26.25 ± 2.25 kg/m². Race and ethnicity data were not collected. Injury mechanisms and classification are provided in Table 4.
| Fracture Characterization | Patient # |
|---|---|
| Mechanism of Injury | |
| Walking | 9 |
| Fall | 3 |
| Sport Injury | 4 |
| Traffic Accident | 4 |
| Type of Ankle Fracture | |
| Isolated Fibular | 7 |
| Bimalleolar (total) | 13 |
| Bimalleolar with posterior (Trimalleolar) | 10 |
| Medial Malleolus Fracture | |
| Classification | |
| (Herscovici) | |
| A | 1 |
| B | 6 |
| C | 13 |
| Medial Malleolus Fracture Type | |
| Stable | 0 |
| Unstable | 20 |
Table 4: Injury and Fracture Characteristics
9
| Tscherne Classification of soft-tissue
| injury | |
|---|---|
| Grade 0 | 20 |
| Grade I | 0 |
| Grade II | 0 |
| Grade III | 0 |
References:
Holweg P, Herber V, Ornig M, Hohenberger G, Donohue N, Puchwein P, Leithner A, Seibert F. A lean bioabsorbable magnesium-zinc-calcium alloy ZX00 used for operative treatment of medial malleolus fractures: early clinical results of a prospective non-randomized first in man study. Bone Joint Res. 2020 Aug 19:9(8):477-483. doi: 10.1302/2046-3758.98.BJR-2020-0017.R2. PMID: 32874554; PMCID: PMC7437522.
Herber V, Labmayr V, Sommer NG, Marek R, Wittig U, Leithner A, Seibert F, Holweg P. Can Hardware Removal be Avoided Using Bioresorbable Mg-Zn-Ca Screws After Medial Malleolar Fracture Fixation? Mid-Term Results of a First-In-Human Study. Injury. 2022 Mar;53(3):1283-1288. doi: 10.1016/j.injury.2021.10.025. Epub 2021 Oct 30. PMID: 34758916.
Note: As stated above, race and ethnicity data were not collected for this clinical dataset. For other patient demographics, such as gender and age, that were collected, the clinical dataset was insufficiently powered to evaluate the effect of these patient demographics on device performance.
Pediatric Extrapolation
In this De Novo request, existing clinical data were not leveraged to support the use of the device in a pediatric patient population.
LABELING
The RemeOs™ Screw LAG Solid labeling includes the following: product description. indications for use, instructions for use, contraindications, warnings, precautions, shelf-life, material composition, absorption byproducts, time to complete absorption, summary of clinical data and surgical technique instructions. The labeling meets the requirements of 21 CFR 801.109. The labeling also includes additional information related to the time for complete product absorption and absorption byproducts.
RISKS TO HEALTH
The table below identifies the risks to health that may be associated with use of an absorbable metallic bone fixation fastener and the measures necessary to mitigate these risks.
Table 5: Identified Risks to Health and Associated Mitigation Measures
10
| Risks to Health | Mitigation Measures |
|---|---|
| Loss of bone fixation resulting from: | |
| Premature device absorption and formation of absorption byproducts Device breakage Galvanic corrosion Device aging | Clinical data |
| Non-clinical performance testing | |
| Shelf-life testing | |
| Labeling | |
| Adverse tissue reaction resulting from: | |
| Device material Device absorption and absorption byproducts | Biocompatibility evaluation |
| Labeling | |
| Infection | Sterilization validation |
| Shelf-life testing | |
| Pyrogenicity testing | |
| Labeling | |
| Difficulties with revision surgery due to screw absorption | Clinical data |
| Labeling |
SPECIAL CONTROLS
In combination with the general controls of the FD&C Act, the absorbable metallic bone fixation fastener is subject to the following special controls:
- (1) Clinical data must demonstrate that the device performs as intended under the anticipated conditions of use. The absorption profile must be characterized to completion (e.g., full absorption). The difficulty of any revision surgeries must be documented.
- (2) Non-clinical performance testing must demonstrate that the product performs as intended under anticipated conditions of use. Testing must:
- Evaluate the complete degradation profile of the device; (i)
- Evaluate the initial mechanical performance; and (ii)
- (iii) Evaluate the mechanical performance as the device degrades.
- 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 (i.e., degradation profile and mechanical performance) over the established shelf-life.
- (7) Labeling must include:
- Material composition; (1)
- (ii) Absorption byproducts;
- (iii) A detailed summary of the product's technical parameters;
- (iv) An expiration date/shelf life;
- Instructions for revision surgery; (v)
- (vi) Time to complete absorption; and
- (vii) A summary of clinical data with the device.
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BENEFIT-RISK DETERMINATION
The risks of the device are based on nonclinical laboratory as well as data collected in a clinical study described above.
BENEFITS:
-
- Fracture fixation and osteosynthesis functionally equivalent to conventional (titanium or stainless steel) bone screws
-
- Reduction in occurrence of long-term pain associated with permanently implanted hardware
-
- Reduced second surgeries for screw removal and associated risks of additional surgical procedure
-
- Avoidance of sensitivities to conventional metallic screws (i.e., nickel, titanium)
-
- Improved clinical imaging (less metal artifact / no metal artifact post-absorption)
-
- Reduced bone stress shielding
RISKS:
-
- Absorption-related screw structural weakness
-
- Absorption-related bone toxicity / device-related fractures
-
- Systemic toxicity
-
- Difficulties with revision surgeries (loss of screw head during absorption)
-
- Reduced fluoroscopic and X-ray visibility
-
- Galvanic corrosion if in contact with non-magnesium hardware
Based on the totality of the evidence, the RemeOs™ Screw LAG Solid demonstrated a reasonable assurance of safety and effectiveness for the device for its intended use/indications for use, and there is a low degree of uncertainty in this finding. In conclusion, the benefits of using the subject device for its intended use/indications for use outweigh the probable risks to health.
Patient Perspectives
Patient perspectives considered for the RemeOs™ Screw LAG Solid included Visual Analogue Scale (VAS) Pain Scale assessments as a secondary safety endpoint evaluated at 0, 2. 6, 12, 24, 52. 104. and 130 weeks. This patient reported outcome (PRO) assessment was used to demonstrate a clinically meaningful improvement in pain reduction.
Benefit/Risk Conclusion
In conclusion, given the available information above, for the following indication statement:
RemeOs™ Screw LAG Solid is intended for the use in traumatic and orthopaedic surgery for the fixation of bone fractures (osteosynthesis) and for the fixation after osteotomies, e.g., for the correction of deformities or malalignments. The absorbable implants serve as temporary fixation and stabilization by osteosynthesis of bone fractures and osteotomies until bony fusion has occurred.
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The RemeOs™ Screw LAG Solid is intended to be used for skeletally mature adults.
The RemeOs™ Screw LAG Solid is indicated for the fixation of the medial malleolus.
The probable benefits outweigh the probable risks for the RemeOs™ Screw LAG Solid. 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 RemeOs™ Screw LAG Solid is granted, and the device is classified as follows:
Product Code: QJD Device Type: Absorbable metallic bone fixation fastener Regulation Number: 21 CFR 888.3041 Class: II