(78 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the spinal implant system, with no mention of AI or ML technology.
Yes
The device is intended to immobilize spinal segments as an adjunct to fusion for various spinal conditions, which is a therapeutic function.
No
The device is a spine system intended for immobilization and fusion of spinal segments, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines physical components made of titanium alloy, such as screws, rods, and connectors, which are hardware. The performance studies also focus on bench testing of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the IMPLANET Spine System is for providing immobilization of spinal segments as an adjunct to fusion. This is a surgical implant used directly in the body for structural support and stabilization.
- Device Description: The description details the physical components of the system (screws, rods, connectors, hooks) made of titanium alloy. These are all physical implants.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. The IMPLANET Spine System is an in vivo (inside the body) device.
N/A
Intended Use / Indications for Use
The IMPLANET Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The IMPLANET Spine System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), turnor, pseudarthrosis, or revision of a failed fusion attempt.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the IMPLANET Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Product codes
NKB, OSH, KWP, MNI, MNH
Device Description
The IMPLANET Spine System is a posterior instrumentation system. The polyaxial screws are made of Ti6Al4V titanium alloy compliant with ISO 5832-3. The polyaxial screw is comprised of three sections: the pedicle screw; the head; and a ring that connects the screw to the head. The polyaxial screws are offered in diameters ranging from 5.0 to 7.5 mm and in lengths ranging from 35 to 60 mm.
The monoaxial pedicle screws are made of Ti6Al4V titanium alloy compliant with ISO 583203 and are available in 5.0 mm, 6.0 mm, 7.0 mm, and 8.0 mm diameters. The screws range in length from 35 to 60 mm.
The system includes both straight and pre-bent rods made of Ti6Al4V titanium alloy.
The transverse connectors are composed of Ti6Al4V titanium alloy compliant with ISO 5832-3. These connectors are used to build a transverse connection between two union rods.
The hooks are made of Ti6AI4V titanium alloy and are provided in multiple configurations.
The IMPLANET Spine System has principles of operation substantially similar to other pedicle screw-based systems for the indications listed.
The IMPLANET Spine System components may be used for posterior pedicle screw fixation in pediatric cases: polyaxial and monoaxial screws, rods, transverse connectors and rods.
The purpose of the subject 510(k) notice is the addition of new indications and the inclusion of intermediate screw sizes to the company's cleared system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar and/or sacral spine
Indicated Patient Age Range
skeletally mature patients, pediatric patients (for adolescent idiopathic scoliosis)
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
This 510(k) premarket notification incorporates by reference the bench testing performed in support of Implanet S.A.'s Calypso System (K120564). All bench testing confirmed that the product met the necessary specifications. Sterilization and shelf life validation testing conducted for the Calypso System in accordance with recognized industry standards are also incorporated by reference. In addition, the biocompatibility of the device was confirmed in accordance with ISO 10993.
Tests performed on the previous version of the device to support substantial equivalence:
- Static axial gripping capacity, static flexion/extension bending, static axial torque . gripping capacity - ASTM F1798;
- Static compression bending ASTM F1717; .
- Static torsion ASTM F1717; .
- Dynamic compression bending ASTM F1717; .
- Shelf life ASTM F 1980; .
- Implant sterilization validation ISO 11137; t
- Instrument cleaning and sterilization validation ISO 17665; .
- Cytotoxicity ISO 10993; .
- . Acute systemic toxicity - ISO 10993.
Tests performed again on the current version of the device to support substantial equivalence:
- Cytotoxicity ISO 10993; ●
- Chemical characterization ISO 10993. .
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
510(k) SUMMARY
Implanet S.A.'s IMPLANET Spine System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Implanet S.A. Technopole Bordeaux Montesquieue Allée François Magendie Phone +33 557 995 555 Facsimile: +33 557 995 700
Contact Person: Franck Rigal, Director of Quality and Regulatory Affairs
Date Prepared: September 15, 2013
Name of Device
IMPLANET Spine System
Common or Usual Name
Spinal fixation device
Classification Name
888.3070 - Spinal Pedicle Fixation Orthosis - NKB, OSH, MNI, MNH
888.3050 - Spinal Interlaminal Fixation Orthosis - KWP
Predicate Devices
Implanet S.A.'s Calypso System (K120564)
Medtronic Sofamor Danek's CD HORIZON® Spinal System (K091445)
Intended Use / Indications for Use
The IMPLANET Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The IMPLANET Spine System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), turnor, pseudarthrosis, or revision of a failed fusion attempt.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the IMPLANET Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
OCT 10 2013
1
Device Description
The IMPLANET Spine System is a posterior instrumentation system. The polyaxial screws are made of Ti6Al4V titanium alloy compliant with ISO 5832-3. The polyaxial screw is comprised of three sections: the pedicle screw; the head; and a ring that connects the screw to the head. The polyaxial screws are offered in diameters ranging from 5.0 to 7.5 mm and in lengths ranging from 35 to 60 mm.
The monoaxial pedicle screws are made of Ti6A!4V titanium alloy compliant with ISO 583203 and are available in 5.0 mm, 6.0 mm, 7.0 mm, and 8.0 mm diameters. The screws range in length from 35 to 60 mm.
The system includes both straight and pre-bent rods made of Ti6Al4V titanium alloy.
The transverse connectors are composed of Ti6Al4V titanium alloy compliant with ISO 5832-3. These connectors are used to build a transverse connection between two union rods.
The hooks are made of Ti6AI4V titanium alloy and are provided in multiple configurations.
The IMPLANET Spine System has principles of operation substantially similar to other pedicle screw-based systems for the indications listed.
The IMPLANET Spine System components may be used for posterior pedicle screw fixation in pediatric cases: polyaxial and monoaxial screws, rods, transverse connectors and rods.
The purpose of the subject 510(k) notice is the addition of new indications and the inclusion of intermediate screw sizes to the company's cleared system.
Technological Characteristics
The IMPLANET Spine System consists of: monoaxial pedicle screws, union rods, transverse connectors, and hooks.
Performance Data
This 510(k) premarket notification incorporates by reference the bench testing performed in support of Implanet S.A.'s Calypso System (K120564), which is listed below. All bench testing confirmed that the product met the necessary specifications. Sterilization and shelf life validation testing conducted for the Calypso System in accordance with recognized industry standards are also incorporated by reference. In addition, the biocompatibility of the device was confirmed in accordance with ISO 10993. A list of the tests performed on the previous version of the device to support substantial equivalence is provided below:
- Static axial gripping capacity, static flexion/extension bending, static axial torque . gripping capacity - ASTM F1798;
- Static compression bending ASTM F1717; .
- Static torsion ASTM F1717; .
- Dynamic compression bending ASTM F1717; .
- Shelf life ASTM F 1980; .
- Implant sterilization validation ISO 11137; t
- Instrument cleaning and sterilization validation ISO 17665; .
- Cytotoxicity ISO 10993; .
- . Acute systemic toxicity - ISO 10993.
2
In addition, a list of the tests performed again on the current version of the device to support substantial equivalence is provided below:
- Cytotoxicity ISO 10993; ●
- Chemical characterization ISO 10993. .
Substantial Equivalence
When used for pediatric use, the IMPLANET Spine System is substantially similar to Implanet S.A.'s Calypso System and Medtronic Sofamor Danek's CD HORIZON® Spinal System. The IMPLANET Spine System has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the IMPLANET Spine System and its predicate devices raise no new issues of safety or effectiveness. Thus, the IMPLANET Spine System is substantially equivalent.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of three curved lines, resembling a person embracing another person. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the graphic. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hamnshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 10, 2013
Implanet S.A. % Ms. Janice M. Hogan Hogan Lovells US LLP 1835 Market Street, 2016 Floor Philadelphia, Pennsylvania 19103
Re: K132303
Trade/Device Name: IMPLANET Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, KWP. MNI. MNH Dated: July 24, 2013 Received: July 24, 2013
Dear Ms. Hogan:
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 (2 ) CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Janice M. Hogan
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Erin I. Keith
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): _ K132303
Device Name: IMPLANET Spine System
Indications for Use:
The IMPLANET Spine System is intended to provide immobilization of spinal segments in skeletally mature palients as an adjunct to fusion of the thoracic, lumbar and/or sacral spine. The IMPLANET Spine System is intended for posterior, non-cervical pedicle and non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal deformities (i.e., scoliosis, kyphosis and/or lordosis), tumor, pseudarthrosis, or revision of a failed fusion attempt.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the IMPLANET Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scollosis. These devices are to be used with autografi and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Amy S. Graf -S
(for RPJ)
(Division Sign-off) Division of Orthopedic Devices 510(k) Number: K132303
Page 1 of 1