(183 days)
No
The 510(k) summary describes a mechanical spinal tethering system and its associated instruments. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies. The performance studies focus on biocompatibility and mechanical testing, typical for this type of implant.
Yes
The device is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures, which fits the definition of a therapeutic device as it directly addresses a medical condition or injury.
No
The device is a temporary implant system for spinal surgery, providing stabilization and aiding in bone repair. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it consists of "temporary implants and a reusable instrument" and describes physical components like "Connector Tether Tensioner Accessory" and "system specific tray." It also details mechanical testing and biocompatibility evaluation, which are relevant to physical devices, not software.
Based on the provided text, the TRANSLACE™ Spinal Tethering System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's a "temporary implant for use in orthopedic surgery" to provide "temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures." This describes a device used within the body during surgery, not a test performed on samples taken from the body.
- Device Description: The description details "temporary implants and a reusable instrument for use in orthopedic spinal surgery." It talks about securing the spine to a rod construct and acting as an alternative to wires and hooks. This further reinforces its role as a surgical implant and instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific substances, or providing diagnostic information based on laboratory tests.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The TRANSLACE™ Spinal Tethering System does not fit this description.
N/A
Intended Use / Indications for Use
The TRANSLACE™ Spinal Tethering System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
- Spinal trauma surgery, used in sublaminar or facet wiring techniques;
- Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic, congenital and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis:
- Spinal degenerative surgery, as an adjunct to spinal fusions.
The TRANSLACE™ Spinal Tethering System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.
Product codes
OWI
Device Description
The TRANSLACE™ Spinal Tethering System consists of temporary implants and a reusable instrument for use in orthopedic spinal surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. This system will allow the spine to be secured to a rod construct without the use of a bone screw. It will act as an alternative to sublaminar wires and hooks.
This system consists of: Connector Tether Tensioner Accessory – system specific tray which may be used to transport and sterilize the subject instruments. The subject TRANSLACE™ Spinal Tethering System devices will be available in similar sizes as the predicate systems.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spinal
Indicated Patient Age Range
patients 8 years of age and older
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)
Comparison of Technological Characteristics with the Predicate Devices: The TRANSLACE™ Spinal Tethering System has the same fundamental technology; polyester, titanium and stainless steel material as the predicate devices. The predicate and subject devices are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the spine.
Performance Data:
Biocompatibility: The biocompatibility evaluation for the TRANSLACE™ Spinal Tethering System devices was conducted in accordance with FDA's Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process" issued June 16, 2016. The subject implants are temporary implants and will be classified as permanent, >30 day body contact according to with FDA's Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process" issued June 16, 2016. The subject Connector is manufactured from identical materials as the predicate devices, in accordance with the following ASTM standard: ASTM F136 – Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The subject Tether is manufactured from polyester and titanium. The following tests have been conducted to ensure biocompatibility:
• Chemical Characterization
• Cytotoxicity
• Acute Systemic Toxicity
• Material Mediated Pyrogenicity
• Implantation
Based on the results, no additional testing was required.
The subject instrument is an external communicating devices and is classified as limited, up to 24 hours of body contact according to with FDA's Guidance for Industry and FDA Staff "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process" issued June 16, 2016. This instrument is manufactured from the same medical grade stainless steel as the predicate devices in accordance with the following ASTM standards: ASTM F899 – Standard Specification for Wrought Stainless Steel for Surgical Instruments ASTM A564 – Standard Specification for Hot-Rolled and Cold Finished Age-Hardening Stainless Steel Bars and Shapes ASTM A693 – Standard Specification for Precipitation-Hardening Stainless and Heat-Resisting Steel Plate, Sheet and Stripe ASTM A276 – Standard Specification for Stainless Bars and Shapes.
Mechanical Testing: In accordance with, Guidance for Industry and FDA Staff – Spinal System 510(k)'s", Medtronic has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices. A combination of engineering rationales and testing were used to establish substantial equivalence. The following bench testing was completed and the results of these tests demonstrated the substantial equivalence of the subject devices to the predicates.
Tether Grip Static Testing (ASTM F1798)
Tether Grip Fatigue Testing (ASTM F1798)
Static Axial Grip Testing (ASTM F1798)
Static Axial Rotational Grip Testing (ASTM F1798)
Compression Fatigue Testing (ASTM F1717)
Static Weld Testing
The following validation activities were completed and met the predetermined acceptance criteria.
Cadaver and/or True-Trainer (Sawbone) Validation Testing
Instructions to Support Reprocessing Validation.
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
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Inc. Ms. Claire Evans Senior Regulatory Affairs Specialist 1800 Pyramid Place
May 16, 2017
Re: K163181
Memphis. Tennessee 38132
Trade/Device Name: TRANSLACE™ Spinal Tethering System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: OWI Dated: April 18, 2017 Received: April 19, 2017
Dear Ms. Evans:
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K163181
Device Name TRANSLACETM Spinal Tethering System
Indications for Use (Describe)
The TRANSLACE™ Spinal Tethering System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
-
Spinal trauma surgery, used in sublaminar or facet wiring techniques;
-
Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic, congenital and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, and spondylolisthesis:
-
Spinal degenerative surgery, as an adjunct to spinal fusions.
The TRANSLACE™ Spinal Tethering System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
MEDTRONIC Sofamor Danek TRANSLACE™ Spinal Tethering System
April 2017
| Submitter: | Medtronic Sofamor Danek, USA Inc. |
|---|---|
| 1800 Pyramid Place | |
| Memphis, Tennessee 38132 | |
| Telephone: (901)396-3133 | |
| Fax: (901) 346-9738 | |
| Contact Person | Claire Evans |
| Senior Regulatory Affairs Specialist | |
| Direct Telephone: (901)399-0804 | |
| Date Prepared | April 18, 2017 |
| Name of Device | TRANSLACE™ Spinal Tethering System |
| Common Name | Connector, Tether, Tensioner |
| Trade Name | TRANSLACE™ Spinal Tethering System |
| Regulatory Class, | |
| Regulation Number, | |
| Regulation Name, and | |
| Device Product Code | Class II 21 CFR 888.3010 Bone Fixation Cerclage OWI |
| Predicate Devices | K110348 Zimmer Universal Clamp (S.E. 8/11/2011) – Primary Predicate |
| K143350 K2M Nile Alternate Fixation System (S.E. 2/25/2015) | |
| The predicates have not been subject to a design related recall. | |
| Reference Devices | K101074 CD Horizon® Spinal System (S.E. 6/22/2010) |
| K152338 Vertex Reconstruction System (S.E. 10/28/2015) | |
| K152241 Medtronic Transportation/Sterilization Cassette System | |
| (S.E.1/20/2016) | |
| Description of Device | The TRANSLACE™ Spinal Tethering System consists of |
| temporary implants and a reusable instrument for use in | |
| orthopedic spinal surgery. The system is intended to provide | |
| temporary stabilization as a bone anchor during the development | |
| of solid bony fusion and aid in the repair of bone fractures. This | |
| system will allow the spine to be secured to a rod construct | |
| without the use of a bone screw. It will act as an alternative to | |
| sublaminar wires and hooks. | |
| This system consists of: | |
| Connector Tether Tensioner Accessory – system specific tray which may be used to transport and sterilize the subject instruments. The subject TRANSLACE™ Spinal Tethering System devices will be available in similar sizes as the predicate systems. | |
| Indications for Use | The TRANSLACE™ Spinal Tethering System is a temporary implant for use in orthopedic surgery. The system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: |
| Spinal trauma surgery, used in sublaminar or facet wiring techniques; Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic, congenital and neuromuscular scoliosis in patients 8 years of age and older, adult scoliosis, kyphosis, and spondylolisthesis; Spinal degenerative surgery, as an adjunct to spinal fusions. The TRANSLACE™ Spinal Tethering System may also be used in conjunction with other medical implants made of similar metals whenever "wiring" may help secure the attachment of other implants. | |
| Comparison of | |
| Technological | |
| Characteristics with the | |
| Predicate Devices: | The TRANSLACE™ Spinal Tethering System has the same fundamental technology; polyester, titanium and stainless steel material as the predicate devices. The predicate and subject devices are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the spine. |
| K110348 Zimmer Universal Clamp (S.E. 8/11/2011) – Primary Predicate K143350 Nile Alternative Fixation System (S.E. 2/25/2015) | |
| The following performance data were provided in support of | |
| substantial equivalence. | |
| Biocompatibility | |
| The biocompatibility evaluation for the TRANSLACE™ Spinal | |
| Tethering System devices was conducted in accordance with | |
| FDA's Guidance for Industry and FDA Staff "Use of International | |
| Standard ISO-10993, Biological Evaluation of Medical Devices | |
| Part 1: Evaluation and Testing within a Risk Management | |
| Process" issued June 16, 2016. | |
| The subject implants are temporary implants and will be classified | |
| as permanent, >30 day body contact according to with FDA's | |
| Guidance for Industry and FDA Staff "Use of International | |
| Standard ISO-10993, Biological Evaluation of Medical Devices | |
| Part 1: Evaluation and Testing within a Risk Management | |
| Process" issued June 16, 2016. | |
| The subject Connector is manufactured from identical materials as | |
| Performance Data: | the predicate devices, in accordance with the following ASTM |
| standard: | |
| • ASTM F136 – Standard Specification for Wrought | |
| Titanium-6 Aluminum-4 Vanadium ELI (Extra Low | |
| Interstitial) Alloy for Surgical Implant Applications | |
| The subject Tether is manufactured from polyester and titanium. | |
| The following tests have been conducted to ensure | |
| biocompatibility: | |
| • Chemical Characterization | |
| • Cytotoxicity | |
| • Acute Systemic Toxicity | |
| • Material Mediated Pyrogenicity | |
| • Implantation | |
| Based on the results, no additional testing was required. | |
| The subject instrument is an external communicating devices and | |
| is classified as limited, up to 24 hours of body contact according | |
| to with FDA's Guidance for Industry and FDA Staff "Use of | |
| International Standard ISO-10993, Biological Evaluation of | |
| Medical Devices Part 1: Evaluation and Testing within a Risk | |
| Management Process" issued June 16, 2016. This instrument is | |
| manufactured from the same medical grade stainless steel as the | |
| predicate devices in accordance with the following ASTM | |
| standards: | |
| ASTM F899 – Standard Specification for Wrought | |
| Stainless Steel for Surgical Instruments ASTM A564 – Standard Specification for Hot-Rolled and | |
| Cold Finished Age-Hardening Stainless Steel Bars and | |
| Shapes ASTM A693 – Standard Specification for Precipitation- | |
| Hardening Stainless and Heat-Resisting Steel Plate, Sheet | |
| and Stripe ASTM A276 – Standard Specification for Stainless Bars | |
| and Shapes | |
| The system specific tray used for shipment and sterilization of | |
| instruments is manufactured from stainless steel, aluminum, nylon | |
| coated stainless steel, radel, polypropylene with the brackets | |
| securing the instruments into the case/tray made of silicone and/or | |
| nylon coated stainless steel and/or polypropylene. These | |
| materials are non-patient contacting and indirect patient contacting | |
| and are the same materials as the predicate. Therefore, no new | |
| biocompatibility testing is required. | |
| Mechanical Testing | |
| In accordance with, Guidance for Industry and FDA Staff – Spinal | |
| System 510(k)'s", Medtronic has evaluated the subject devices to | |
| demonstrate substantial equivalence to the predicate devices. A | |
| combination of engineering rationales and testing were used to | |
| establish substantial equivalence. The following bench testing | |
| was completed and the results of these tests demonstrated the | |
| substantial equivalence of the subject devices to the predicates. | |
| Tether Grip Static Testing (ASTM F1798) Tether Grip Fatigue Testing (ASTM F1798) Static Axial Grip Testing (ASTM F1798) Static Axial Rotational Grip Testing (ASTM F1798) Compression Fatigue Testing (ASTM F1717) | |
| Static Weld Testing The following validation activities were completed and met the predetermined acceptance criteria. Cadaver and/or True-Trainer (Sawbone) Validation Testing Instructions to Support Reprocessing Validation. | |
| Conclusion: | Based on the risk analysis, test results, and additional supporting documentation provided in the pre-market notification, the subject TRANSLACET™ Spinal Tethering System is as safe and effective as the following predicates: K110348 Zimmer Universal Clamp (S.E. 8/11/2011) – |
| Primary Predicate K143350 Nile Alternative Fixation System (S.E. 2/25/2015) |
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