(220 days)
No
The 510(k) summary describes a physical bone screw and its material properties and performance through mechanical and biological testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is a bioabsorbable bone screw used in orthopedic surgery to fix soft tissues to bone, which is a therapeutic intervention aimed at treating injuries or conditions.
No
The device is described as a fixation screw used in orthopedic surgery to fix soft tissues to bone. Its function is mechanical support, not the detection, diagnosis, or monitoring of a disease or condition.
No
The device is a physical bone screw made of bioabsorbable materials, not software. The description details its composition, intended use in surgery, and physical performance testing.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, diagnose conditions, or monitor treatment.
- Device Function: The description clearly states that this device is a "Sterile bioabsorbable bone screw" used for "fixing soft tissue such as ligaments, tendons, and the articular capsules to bone" during "orthopedic surgery."
- Mechanism of Action: The device is implanted directly into the body to provide mechanical support and fixation. It does not interact with or analyze biological specimens outside of the body.
The information provided describes a surgical implant, not a diagnostic tool that analyzes samples.
N/A
Intended Use / Indications for Use
Sterile bioabsorbable bone screw (Biocomposite ACL screw) is a fixation screw that fixes soft tissue such as ligaments, tendons, and the articular capsules to bone, and is used in orthopedic surgery(Cruciate ligament reconstruction procedures).
Product codes
MAI
Device Description
The Sterile bioabsorbable bone screw (Biocomposite ACL screw) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery. The implanted screw is made of poly(L-lactide-co-glycolide), PLGA and tri-calciumphosphate(S-TCP). Poly(L-lactide-co-glycolide), PLGA is gradually decomposed in vivo by hydrolysis and eventually excreted in carbon dioxide and water. Tri-calciumphosphate(ß-TCP) is gradually degraded in vivo by hydrolysis and eventually re-used as a calcium source. Sterile bioabsorbable bone screw (Biocomposite ACL screw) is supplied EO gas sterile state and it is packed in Aluminum Pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone (for ligaments, tendons, and articular capsules)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The following standards were used to support substantial equivalence:
Mechanical Performance
- ASTM F2502:17 Standard Specification and test methods for absorbable plates and screws for internal fixation implants
- ISO 13781:2017 Implants for surgery Homopolymers, copolymers and blends on poly(lactide) In vitro degradation testing
Sterilization, Shelf-life and Packaging for Sterile Product
- ISO 11135:2014, Sterilization of health care products Ethylene oxide Requirements for the development validation and routine control of a sterilization and routine control of a sterilization process for medical devices.
- ISO 11138-1:2006, Sterilization of health care products Biological indicators Part 1: General requirements
- ISO 11138-2:2009, Sterilization of health care products Biological indicators Part 2: Biological indicators for ethylene oxide sterilization processes
- ISO 11140-1:2014, Sterilization of health care products Chemical indicators Part 1: General requirements
- ISO 11737-1:2018 Sterilization of medical devices Microbiological methods- Part 1: Estimation of population of microorganisms on products
- ISO 11737-2:2009 Sterilization of medical devices Microbiological methods- Part 2: Tests of sterility performed in the validation of a sterilization process
- ISO 11607-1:2006/AMD1:2014 Packaging for terminally sterilized medical devices part 1: requirements for materials, sterile barrier systems and packaging system
- ISO 11607-2:2006/AMD1:2014 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
- ASTM F1980:2016 Standard guide for accelerated aging of sterile barrier systems for medical devices
- ASTM F88/F88M:2015 Standard test method for seal strength of flexible barrier materials.
- ASTM F1929:2015 Standard test method for detecting seal leaks in porous medical packaging by dye penetration
Bacterial Endotoxin
- USP Bacterial Endotoxin Test
- USP Medical Devices-Bacterial Endotoxin and Pyrogen Tests
Biocompatibility
Sterile bioabsorbable bone screw (Biocomposite ACL screw) has been evaluated for biocompatibility according to ISO 10993.
Summary of Performance
All specimens selected (worst-case) to verify the performance of the test criteria established based on literatures and comparison with the predicate device. Therefore, the entire model was proven.
- Axial Pullout Strength: PASS (Test referring ASTM F2502-A3.Test Method for Axial Pullout of Absorbable Bone Screws. After fully inserting the screw into the artificial bone (20PCF), Apply tensile load to the specimen at a rate 5mm/min until the screw fails or releases from the block. Measure the maximum load.)
- Torsional Yield Strength: PASS (Test referring ASTM F2502-A1.Test Method for Determining the Torsion Properties of Absorbable Bone Screws. After placing the specimen in the holding device, Rotate the screw in inserting direction at a rate of 1 revolution/min. Torsional yield strength is determined by an off-set method (2 degree off-set) on the torque versus rotation angle curve measured in the test.)
- Driving Torque: PASS (Test referring ASTM F2502-A2.Test Method for Driving Torque of Absorbable Bone Screws. Make a hole in the fixed artificial bone (20PCF) using an instrument compatible with the product. Measure the maximum strength when the screw is inserted 4 revolutions at a rate of 5 revolutions per minute. * Inserting load (axial load) = 1.14kgf)
- Degradation testing: PASS (Mechanical performance assessed after degradation according to ISO 13781)
- Fatigue: PASS (After fully inserting the screw with the tendon into the fixed artificial bone (20PCF), a fatigue tensile load of 70 to 220N on the tendon is repeated 1000 cycles at 1 Hz.)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
August 27, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services USA. To the right of the seal is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.
OSTEONIC Co., Ltd. % Sanglok Lee Manager WISE COMPANY Inc. #507, #508, 166 Gasan digital 2-ro Geumcheon-gu, Seoul 08507 South Korea
Re: K210122
Trade/Device Name: Sterile Bioabsorbable Bone Screw (Biocomposite ACL Screw) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI Dated: July 20, 2021 Received: July 22, 2021
Dear Sanglok Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laura C. Rose -S
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210122
Device Name
Sterile bioabsorbable bone screw (Biocomposite ACL screw)
Indications for Use (Describe)
Sterile bioabsorbable bone screw (Biocomposite ACL screw) is a fixation screw that fixes soft tissue such as ligaments, tendons, and the articular capsules to bone, and is used in orthopedic surgery(Cruciate ligament reconstruction procedures).
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the Osteonic logo. The logo consists of a blue geometric shape on the left and the word "OSTEONIC" in dark gray on the right. The geometric shape is a diamond with a smaller diamond inside it.
1206Ho, 38, Digital-ro 29 Tel: +82(2)-6902-8400 Fax: +82(2)-6902-8401 Home page: http://www.osteonic.com
K210122 - Page 1 of 5
The assigned 510(k) Number: K210122
1. 510(k) Summary Date: 15.01.2021
2. Applicant
DaKyung Ham OSTEONIC Co., Ltd. 303Ho, 405Ho, 505-3Ho, 505-3Ho, 902Ho, 1004Ho, 1201Ho, 1206Ho, 38 Digital-ro 29-gil, Gurogu, Seoul, Korea, 102Ho, 103Ho, 24, Digital-ro 27-gil, Guro-gu, Seoul, Korea TEL: +82-2-6902-8426 FAX: +82-2-6902-8401 Email: dakham@osteonic.com
3. Submission Correspondent
Sang-lok, Lee Wise COMPANY Inc. #507, #508, 166 Gasan digital 2-ro, Geumcheon-gu, Seoul, Korea TEL: +82 70 8812 3619 / +82 2 831 3615 FAX: +82 50 4031 3619 Email: info@wisecompany.org
4. Subject Device Identification
-
- Trade Name: Sterile bioabsorbable bone screw (Biocomposite ACL screw)
-
- Common Name: Sterile bioabsorbable bone screw (Biocomposite ACL screw)
-
- Classification Name: fastener, fixation, biodegradable, soft tissue
-
- Product Code: MAI
-
- Panel: Orthopedic
-
- Regulation Number: 21 CFR 888.3030
-
- Device Class: II
5. Indication for use
Sterile bioabsorbable bone screw (Biocomposite ACL screw) is a fixation screw that fixes soft tissue such as ligaments, tendons, and the articular capsules to bone, and is used in orthopedic surgery(Cruciate ligament reconstruction procedures).
4
Image /page/4/Picture/0 description: The image contains the logo for Osteonic. The logo consists of a blue geometric shape resembling a stylized diamond or square with an opening in the center, positioned to the left of the company name. The text "OSTEONIC" is written in a bold, dark gray sans-serif font to the right of the geometric shape.
1206Ho. 38. Digital-ro 29 Tel: +82(2)-6902-8400 Fax: +82(2)-6902-8401 Home page: http://www.osteonic.com
K210122 - Page 2 of 5
6. Predicate devices
Predicate device
-
- 510(k) Number: K143660
-
- Device Name: Milagro/Milagro Advance Interference Screw
-
- Manufacturer: DePuy Mitek, Inc.
Reference device
-
- 510(k) Number: K103831
-
- Device Name: Milagro Interference screw
-
- Manufacturer: DePuy Mitek, Inc.
Reference device
-
- 510(k) Number: K202806
-
- Device Name: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi SelfPunching)
- Manufacturer: Osteonic Co., Ltd.
7. Device Description
The Sterile bioabsorbable bone screw (Biocomposite ACL screw) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.
The implanted screw is made of poly(L-lactide-co-glycolide), PLGA and tri-calciumphosphate(S-TCP). Poly(L-lactide-co-glycolide), PLGA is gradually decomposed in vivo by hydrolysis and eventually excreted in carbon dioxide and water. Tri-calciumphosphate(ß-TCP) is gradually degraded in vivo by hydrolysis and eventually re-used as a calcium source.
Sterile bioabsorbable bone screw (Biocomposite ACL screw) is supplied EO gas sterile state and it is packed in Aluminum Pouch.
8. Non-Clinical Test Conclusion
-
- General Information
Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The following standards were used to support substantial equivalence:
- General Information
▪ Mechanical Performance
- ASTM F2502:17 Standard Specification and test methods for absorbable plates and screws for internal fixation implants
- ISO 13781:2017 Implants for surgery Homopolymers, copolymers and blends on poly(lactide) In vitro degradation testing
- = Sterilization, Shelf-life and Packaging for Sterile Product
- ISO 11135:2014, Sterilization of health care products Ethylene oxide Requirements for the development validation and routine control of a sterilization and routine control of a sterilization process for medical devices.
- ISO 11138-1:2006, Sterilization of health care products Biological indicators Part 1: General requirements
- ISO 11138-2:2009, Sterilization of health care products Biological indicators Part 2: Biological
5
Image /page/5/Picture/1 description: The image shows the Osteonic logo. The logo consists of a blue geometric shape on the left and the word "OSTEONIC" in dark gray on the right. The geometric shape is a diamond with a stylized "O" inside, created by overlapping lines. The word "OSTEONIC" is in a bold, sans-serif font.
1206Ho. 38. Digital-ro 29-gil. Tel: +82(2)-6902-8400 Fax: +82(2)-6902-8401 Home page: http://www.osteonic.com
K210122 - Page 3 of 5
indicators for ethylene oxide sterilization processes
- ISO 11140-1:2014, Sterilization of health care products Chemical indicators Part 1: General requirements
- ISO 11737-1:2018 Sterilization of medical devices Microbiological methods- Part 1: Estimation of population of microorganisms on products
- ISO 11737-2:2009 Sterilization of medical devices Microbiological methods- Part 2: Tests of sterility performed in the validation of a sterilization process
- ISO 11607-1:2006/AMD1:2014 Packaging for terminally sterilized medical devices part 1: requirements for materials, sterile barrier systems and packaging system
- ISO 11607-2:2006/AMD1:2014 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
- ASTM F1980:2016 Standard guide for accelerated aging of sterile barrier systems for medical devices
- ASTM F88/F88M:2015 Standard test method for seal strength of flexible barrier materials.
- ASTM F1929:2015 Standard test method for detecting seal leaks in porous medical packaging by dye penetration
▪ Bacterial Endotoxin
- USP Bacterial Endotoxin Test
- USP Medical Devices-Bacterial Endotoxin and Pyrogen Tests
2) Summary of Biocompatibility
Sterile bioabsorbable bone screw (Biocomposite ACL screw) has been evaluated for biocompatibility according to ISO 10993.
3) Summary of Performance
All specimens selected (worst-case) to verify the performance of the test criteria established based on literatures and comparison with the predicate device. Therefore, the entire model was proven.
| No. | Test Article | Test Method | Result |
|---|---|---|---|
| 1 | Axial Pullout Strength | Test referring ASTM F2502-A3.Test Method for Axial | |
| Pullout of Absorbable Bone Screws. | |||
| After fully inserting the screw into the artificial bone (20PCF), | |||
| Apply tensile load to the specimen at a rate 5mm/min until the | |||
| screw fails or releases from the block. Measure the maximum | |||
| load. | PASS | ||
| 2 | Torsional Yield Strength | Test referring ASTM F2502-A1.Test Method for Determining | |
| the Torsion Properties of Absorbable Bone Screws. | |||
| After placing the specimen in the holding device, Rotate the | |||
| screw in inserting direction at a rate of 1 revolution/min. | |||
| Torsional yield strength is determined by an off-set method (2 | |||
| degree off-set) on the torque versus rotation angle curve | |||
| measured in the test. | PASS | ||
| 3 | Driving Torque | Test referring ASTM F2502-A2.Test Method for Driving | |
| Torque of Absorbable Bone Screws. | |||
| Make a hole in the fixed artificial bone (20PCF) using an | |||
| instrument compatible with the product. Measure the | |||
| maximum strength when the screw is inserted 4 revolutions at | |||
| a rate of 5 revolutions per minute. |
- Inserting load (axial load) = 1.14kgf | PASS |
| 4 | Degradation testing | Mechanical performance assessed after degradation according
to ISO 13781 | PASS |
| 5 | Fatigue | After fully inserting the screw with the tendon into the fixed
artificial bone (20PCF), a fatigue tensile load of 70 to 220N | PASS |
6
Image /page/6/Picture/0 description: The image shows the logo for Osteonic. The logo consists of a blue diamond shape with a stylized "O" inside, followed by the word "OSTEONIC" in bold, dark blue letters. The logo is simple and modern, with a focus on the company name.
OSTEONIC Tel: +82(2)-6902-8400 Fax: +82(2)-6902-8401 Home page: http://www.osteonic.com
K210122 - Page 4 of 5
on the tendon is repeated 1000 cycles at 1 Hz.
9. Substantially Equivalent Conclusion
Table 1: Substantial Equivalence Comparison
| Product
Name | SUBJECT Device | PREDICATE Device
Milagro/Milagro Advance
Interference Screw (K143660) | REFERENCE Device 1
Milagro Interference screw
(K103831) | Equivalence
Discussion |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Product
code | MAI | MAI | MAI, HWC | Same |
| Regulatory
class | Class II | Class II | Class II | Same |
| Regulation
Number | 21 CFR 888.3030 | 21 CFR 888.3030 | 21 CFR 888.3040 | Same |
| Intended
Use | Sterile bioabsorbable bone
screw (Biocomposite ACL
screw) is a fixation screw that
fixes soft tissue such as
ligaments, tendons, and the
articular capsules to bone, and
is used in orthopedic
surgery(Cruciate ligament
reconstruction procedures). | Milagro Interference
screw(5x12,6x12,7x15,8x15)
The MILAGRO BR
Interference screws are
designed to attach soft tissues
to bone in Ortohpedic surgical
procedures for the following
indications:
Shoulder : Proximal Biceps
Tenodesis, Acromio-
Clavicular Repair
Elbow: Distal Biceps
Tenodesis, Ulnar Collateral
Ligament Repair
Knee: Collateral Ligament
Repair, Medial Patellofemoral
Ligament Reconstruction
(patella fixation)
Milagro Advance Interference
screw(7x23,8x23,9x23)
The MILAGRO ADVANCE
Interference screw is intended
for attachment of soft tissue
grafts or bone-tendon-bone
grafts to the tibia and/or femer
during cruciate ligament
reconstruction procedures.
Additionally, the 7, 8 and
9mm x 23mm screws are
indicated for : medial and
lateral collateral ligament
repair, medial patellofemoral
ligament reconstruction(femer
fixation) of the knee, proximal
bicep tenodesis in the shoulder
and distal bicep tenodesis in
the elbow. | Knee :
- Attachment of a bone-tendon-
bone(BTB)graft to the tibia
and/or femur during cruciate
ligament
reconstruction
procedure. - Attachment of a soft tissue
(ST)graft to the tibia and/or
femur during cruciate ligament
reconstruction procedures. - Medial and lateral collateral
ligament repair
Shoulder :
Proximal bicep tenodesis
Elbow :
Distal bicep tenodesis | Same |
| Operating
Principles | Sterile bioabsorbable bone
screw (Biocomposite ACL
screw) is a fixation screw that
fixes soft tissue such as
ligaments, tendons, and the
articular capsules to bone, and | Milagro/Milagro Advance
Interference Screw is a
fixation screw that fixes soft
tissue such as ligaments,
tendons, and the articular
capsules to bone, and is used | Milagro Interference screw
is a fixation screw that fixes
soft tissue such as ligaments,
tendons, and the articular
capsules to bone, and is used
in orthopedic surgery(Cruciate | Same |
| | | | | |
| | is used in orthopedic
surgery(Cruciate ligament
reconstruction procedures). | in orthopedic surgery(Cruciate
ligament reconstruction
procedures). | ligament reconstruction
procedures). | |
| Material | PLGA + β-TCP | Composite of β-TCP and
PLGA copolymer | Absorbable Poly(lactide -co-
glycolide) polymer and
Tricalcium Phosphate(TCP) | Same |
| Product
Size | Ø7.0 x (25, 30) mm
Ø8.0 x (23, 25, 28, 30) mm
Ø9.0 x (23, 25, 28, 30) mm
Ø10.0 x (23, 25, 28, 30) mm | Ø5.0 x 12 mm
Ø6.0 x 12 mm
Ø7.0 x (15, 23) mm
Ø8.0 x (15, 23) mm
Ø9.0 x 23 mm | Ø5.0 x (23, 30) mm
Ø6.0 x (23, 30) mm
Ø7.0 x (23, 30) mm
Ø8.0 x (23, 30) mm
Ø9.0 x (23, 30, 35) mm
Ø10.0 x (23, 30, 35) mm
Ø11.0 x (30, 35) mm
Ø12.0 x (30, 35) mm | Similar |
| Sterilization | Sterile (EO gas sterilization) | Sterile (EO gas sterilization) | Sterile (EO gas sterilization) | Same |
| Single Use/
Reuse | Single use | Single use | Single use | Same |
| Packaging | 1 EA / BOX | 1 EA / BOX | 1 EA / BOX | Same |
7
Image /page/7/Picture/0 description: The image shows the logo for Osteonic. The logo consists of a blue geometric shape resembling a stylized diamond or square with internal lines, positioned to the left of the company name. The text "OSTEONIC" is written in a bold, dark gray sans-serif font.
1206Ho, 38, Digital-ro 29-gil, Guro-gu, Seoul, Korea Tel: +82(2)-6902-8400 Fax: +82(2)-6902-8401 Home page: http://www.osteonic.com
K210122 - Page 5 of 5
Based on above, the subject device, Sterile absorbable bone screw (Biocomposite ACL screw), is determined to be Substantially Equivalent (SE) to the predicate devices, Milagro Advance Interference Screw (K143660) in respect of safety and effectiveness.