(106 days)
Not Found
No
The summary describes a mechanical spinal implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is intended to provide immobilization of spinal segments as an adjunct to fusion for various spinal conditions, which directly addresses disease and injury.
No
This device is described as a "posterior instrumentation system" intended as an "adjunct to fusion" of the spine, which means it is used for surgical stabilization, not for diagnosing conditions.
No
The device description clearly outlines physical hardware components made of titanium alloy and Cobalt Chromium, such as screws, rods, connectors, and hooks, intended for surgical implantation. There is no mention of software as the primary or sole component.
Based on the provided information, 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 "immobilization of spinal segments... as an adjunct to fusion." This describes a surgical implant used to treat structural issues in the spine.
- Device Description: The device description details the physical components of the system (screws, rods, connectors, hooks) made of titanium alloy and cobalt chromium. These are all physical implants and surgical tools.
- Performance Studies: The performance studies focus on mechanical strength and biocompatibility, which are relevant to surgical implants, not diagnostic tests.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (blood, tissue, etc.) or to provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The IMPLANET Spine System is a therapeutic device used in surgery.
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 deformities (i.e., scoliosis, kyphosis and/or lordlosis), 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 scoliosis. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Product codes
NKB, OSH, MNH, MNI, KWP
Device Description
The IMPLANET Spine System is a posterior instrumentation system. The polvaxial 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 5832-3 and are available in 5.0 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 Ti6AI4V titanium alloy.
The transverse connectors are composed of Ti6AI4V 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 Ti6Al4V titanium alloy and are provided in multiple configurations.
The purpose of this 510(k) is to extend the ISS line to include:
- New monoaxial and polyaxial screws .
- Cobalt Chromium rods
- New Ti6Al4V titanium alloy rods ●
- Offset connector and associated offset connector screws
- Rod to rod connectors
- . New instruments
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 for a line extension to incorporate additional device dimensions and Cobalt Chromium rods, as well as compatible additional instruments, 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, adolescent idiopathic scoliosis (pediatric patients)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The modified IMPLANET Spine System was tested to the following performance standards:
- 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; ●
- Cytotoxicity ISO 10993-5; .
- Acute systemic toxicity - ISO 10993-11.
All results confirmed that the modifications to the device described in this submission do not adversely impact mechanical strength compared to the predicate. In addition, the device is biocompatible.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 14, 2015
Implanet S.A. % Ms. Janice M. Hogan Hogan Lovells US, LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K143731
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, MNH, MNI, KWP Dated: January 14, 2015 Received: January 14, 2015
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 (21 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
1
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 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/Resourcesfor You/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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
IMPLANET Spine System
Indications for Use (Describe)
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 deformities (i.e., scoliosis, kyphosis and/or lordlosis), 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 scoliosis. These devices are to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
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510(k) SUMMARY
lmplanet S.A.'s IMPLANET Spine System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Implanet S.A. Technopole Bordeaux Montesquieu Allée François Magendie France Phone +33 557 995 555 Facsimile: +33 557 995 700
Contact Person: Regis Le Couedic, Director of Quality and Requlatory Affairs and CTO
Date Prepared: April 10, 2015
Name of Device
IMPLANET Spine System
Common or Usual Name
Pedicle screw spinal system
Classification Name
888.3070 - Spinal Pedicle Fixation Orthosis - NKB, OSH, MNI, MNH
888.3050 - Spinal Interlaminal Fixation Orthosis - KWP
Predicate Devices
IMPLANET Spine System (K120564; K132303 (Primary Predicate))
Purpose of the 510(k) Notice
The IMPLANET Spine System (ISS) is a modification to the cleared IMPLANET Spine System (K120564; K132303).
Intended Use
The IMPLANET Spine System is intended to provide immobilization and stabilization 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
4
(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 lordlosis), 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 scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Device Description
The IMPLANET Spine System is a posterior instrumentation system. The polvaxial 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 5832-3 and are available in 5.0 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 Ti6AI4V titanium alloy.
The transverse connectors are composed of Ti6AI4V 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 Ti6Al4V titanium alloy and are provided in multiple configurations.
The purpose of this 510(k) is to extend the ISS line to include:
- New monoaxial and polyaxial screws .
- Cobalt Chromium rods
- New Ti6Al4V titanium alloy rods ●
- Offset connector and associated offset connector screws
- Rod to rod connectors
- . New instruments
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 for a line extension to incorporate additional device dimensions and Cobalt Chromium rods, as well as compatible additional instruments, to the company's cleared system.
Technological Characteristics
The IMPLANET Spine System is composed of smooth fusion rods, pedicle screws, bolts, rod to rod and transverse connectors offset connector and associated offset connector screws, and spinal hooks.
5
Performance Data
The modified IMPLANET Spine System was tested to the following performance standards:
- 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; ●
- Cytotoxicity ISO 10993-5; .
- Acute systemic toxicity - ISO 10993-11.
All results confirmed that the modifications to the device described in this submission do not adversely impact mechanical strength compared to the predicate. In addition, the device is biocompatible.
Substantial Equivalence
The ISS has the same intended use and similar indications, principles of operation, and technological characteristics as the predicate device. The minor differences in the modified device's technological characteristics, namely a line extension to incorporate additional device dimensions and Cobalt Chromium rods as well as compatible additional instruments, do not raise any new questions of safety or effectiveness. Performance data demonstrates that the ISS is substantially equivalent to its predicate device.
Conclusions
The modified ISS is substantially equivalent to the predicate, ISS system.