(135 days)
Not Found
No
The document describes spinal implants and their MR compatibility and sterilization. There is no mention of AI or ML in the intended use, device description, or performance studies. The purpose of the submission is solely to add MR Conditional labeling and update sterilization recommendations.
Yes.
The device is intended to immobilize and stabilize spinal segments as an adjunct to fusion for a variety of acute and chronic instabilities of the spine, and to replace vertebral bodies and facilitate fusion, indicating a therapeutic purpose and direct medical benefit.
No
Explanation: The provided text describes the Easyspine Posterior Spinal System and other LDR Spine implant systems as medical devices designed to stabilize and promote fusion in the spine. Their intended use is to treat various spinal conditions by providing immobilization and stabilization as an adjunct to fusion or as vertebral body replacements. There is no mention of the device being used for diagnosis or detection of a disease or condition. The text focuses on therapeutic and supportive functions.
No
The device description explicitly states that the devices are "medical devices designed to stabilize and promote fusion in the cervical and thoracolumbar spine" and are made of "titanium alloy, tantalum, and PEEK OPTIMA® LT1". This indicates they are physical implants, not software. The submission is for adding MR Conditional labeling and updating sterilization recommendations for these physical devices.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a surgical implant system designed to provide immobilization and stabilization of spinal segments and replace vertebral bodies. This is a therapeutic and structural function within the body.
- Device Description: The device description details the materials used in the manufacture of the implants (titanium alloy, tantalum, PEEK) and their purpose in stabilizing and promoting fusion in the spine.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples such as blood, urine, or tissues to detect diseases or other conditions. The provided text does not mention any testing of samples outside the body.
- Performance Studies: The performance studies described focus on the physical properties of the implants in the MR environment and sterilization validation, not on diagnostic accuracy or the analysis of biological samples.
The device is a surgical implant, not a diagnostic tool used on samples outside the body.
N/A
Intended Use / Indications for Use
The Easyspine® Posterior Spinal System is a posterior, non-cervical pedicle and non-pedicle system 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 of the thoracic, lumbar and sacral spine:
- 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
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudoarthrosis
- Failed previous fusion
When used as an intervertebral body fusion device, the MC+ Implant System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment prior to treatment with the device. The MC+ Implant System is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation is required to properly utilize this system.
When used as a vertebral body replacement device. the MC+ Implant System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bone.
The ROI Partial Vertebral Body Replacement System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. ROI Partial Vertebral Body Replacement implants may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize the system.
When used as an intervertebral body fusion device. the ROI-A Implant System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
The ROI-C Implant System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The LDR Spine ROI-C Implant System is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.
When used as an intervertebral body fusion device, the ROI-T Implant System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
When used as a vertebral body replacement device, the ROI-T Implant System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. Supplemental internal fixation is required to properly utilize the system. These devices are intended to be used with autograft or allograft bone.
The ROI-T implants may be implanted singularly or in pairs.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNI, MNH, KWP, MAX, ODP, OVD, OVE, MQP
Device Description
The LDR Spine implant systems identified above are medical devices designed to stabilize and promote fusion in the cervical and thoracolumbar spine. The materials used in their manufacture are titanium alloy (ASTM F136), tantalum (ASTM F560), and PEEK OPTIMA® LT1.
The purpose of this 510(k) submission is solely to add MR Conditional labeling to LDR Spine's vertebral body replacement and interbody fusion cage systems (ROI, MC+, ROI-A, ROI-C, ROI-T), and to update the steam sterilization recommendations for all non-sterile instruments, cases, and trays for the above listed vertebral body replacement and intervertebral body fusion cages, as well as the Easyspine pedicle screw system.
The subject device systems remain unchanged relative to their predicates with respect to indications for use, material, design and performance characteristics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical, thoracolumbar spine, thoracic, lumbar and sacral spine, C2-T1, T1 to L5, L2 to S1
Indicated Patient Age Range
skeletally-mature patients
Intended User / Care Setting
Prescription Use
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
MRI compatibility testing was completed using methods described in the following ASTM standards:
- ASTM F2052-06
- ASTM F2213-06
- ASTM F2119-07
- ASTM F2182-09
Non-clinical performance testing for MR compatibility was conducted on the ROI, MC+, ROI-A, ROI-C, and ROI-T vertebral body replacement and intervertebral body fusion implants and included:
- Magnetically-induced angular displacement
- Magnetically-induced torque
- MR imaging artifact analysis
- Differential heating in the MR environment
A Steam Sterilization validation for the LDR Spine non-sterile devices associated with the Easyspine pedicle screw system and the ROI, MC+, ROI-A, ROI-C, and ROI-T vertebral body replacement and intervertebral body fusion implants was also performed in accordance with the following standards:
- AAMI TIR12
- ANSI AAMI ST79
- ISO 17655-1
- AAMI TIR 39
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test results indicate that the PEEK interbody fusion cages and anchor plates (where applicable) and vertebral body replacement devices meet the ASTM recommendations for MR-Conditional labeling in terms of device heating, magnetically induced displacement, and MRI artifacts.
Testing consisted of steam sterilization testing which confirmed that the non-sterile devices achieved a SAL of 10-8 when exposed to a steam sterilization cycle meeting the recommended cycle parameters outlined in AAMI ANSI ST79.
Clinical testing was not required to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K043094, K063794, K070341, K082592, K043349, K091088, K082262, K090507
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 LDR. The logo consists of a stylized eye graphic to the left of the letters "LDR" in bold, sans-serif font. Below the letters is the tagline "a passion for innovation" in a smaller, thinner font.
Owner's Name & Address:
Contact Person:
Date:
Trade Name:
Common Name:
Classification:
Predicate Devices:
510(k) Summary
LDR Spine USA 13785 Research Blvd. Suite 200 Austin, TX 78750
Bradlev W. Strasser Regulatory Affairs Project Manager Phone: (512) 344-3395 Fax: (512) 795-8306 Email: bradstrasser@ldrspine.com
August 06, 2012
LDR Spine USA EasySpine® Posterior Spinal System LDR Spine USA MC+TM Implant System LDR Spine USA ROI® Implant System LDR Spine USA ROI-A® İmplant System LDR Spine USA ROI-C® Implant System LDR Spine USA ROI-T® Implant System
Spinal Pedicle Screws Intervertebral Body Fusion Device Spinal Vertebral Body Replacement Device
NKB (21 CFR 888.3070) - Pedicle Screw Spinal System
MAX (21 CFR 888.3080) - Intervertebral Fusion Device with Bone Graft, Lumbar
MNH (21 CFR 888.3070) - Orthosis, Spondylolisthesis Spinal Fixation
MNI (21 CFR 888.3070) - Orthosis, Spinal Pedicle Fixation
KWP (21 CFR 888.3050) - Orthosis, Spinal Interlaminal Fixation
MQP (21 CFR 888.3060) - Spinal Vertebral Body Replacement Device
OVD (21 CFR 888.3080) - Intervertebral Fusion Device with Integrated Fixation, Lumbar
ODP (21 CFR 888.3080) - Intervertebral Fusion Device with Bone Graft, Cervical
OVE (21 CFR 888.3080) - Intervertebral Fusion Device with Integrated Fixation, Cervical
Easyspine® Posterior Spinal System K043094, K063794, K070341, K082592
ROI® Implant System K043349
MC+TM Implant System K091088
AUG 2 4 2012
1
Image /page/1/Picture/1 description: The image shows the logo for LDR. The logo consists of a stylized eye with a person inside of it, followed by the letters "LDR" in bold black font. Below the letters is the phrase "a passion for innovation" in a smaller font.
Device Description:
Indications for Use:
Non-Clinical Performance Data:
510(k) Summary
ROI-A® Implant System K082262, K090507 ROI-C® Implant System K091088 ROI-T® Implant System K082262
The LDR Spine implant systems identified above are medical devices designed to stabilize and promote fusion in the cervical and thoracolumbar spine. The materials used in their manufacture are titanium alloy (ASTM F136), tantalum (ASTM F560), and PEEK OPTIMA® LT1
The purpose of this 510(k) submission is solely to add MR Conditional labeling to LDR Spine's vertebral body replacement and interbody fusion cage systems (ROI, MC+, ROI-A, ROI-C, ROI-T), and to update the steam sterilization recommendations for all non-sterile instruments, cases, and trays for the above listed vertebral body replacement and intervertebral body fusion cages, as well as the Easyspine pedicle screw system.
The subject device systems remain unchanged relative to their predicates with respect to indications for use, material, design and performance characteristics.
The indications for use for systems discussed in this submission are identical to those cleared previously in predicate premarket notifications.
MR compatibility testing was completed using methods described in the following ASTM standards:
- ASTM F2052-06 .
- . ASTM F2213-06
- ASTM F2119-07 .
- ASTM F2182-09 .
Non-clinical performance testing for MR compatibility was conducted on the ROI, MC+, ROI-A, ROI-C, and ROI-T vertebral body replacement and intervertebral body fusion implants and included:
- . Magnetically-induced angular displacement
- Magnetically-induced torque ●
- MR imaging artifact analysis ●
- Differential heating in the MR environment .
Test results indicate that the PEEK interbody fusion cages and anchor plates (where applicable) and vertebral body replacement devices meet the ASTM recommendations for MR-Conditional labeling in terms of device heating, magnetically induced displacement, and MRI artifacts.
2
Image /page/2/Picture/0 description: The image shows the logo for LDR, which is a company that has "a passion for innovation". The logo consists of a stylized human figure inside of a circle, followed by the letters "LDR" in bold, sans-serif font. Below the letters is the phrase "a passion for innovation" in a smaller, serif font.
510(k) Summary
A Steam Sterilization validation for the LDR Spine non-sterile devices associated with the Easyspine pedicle screw system and the ROI, MC+, ROI-A, ROI-C, and ROI-T vertebral body replacement and intervertebral body fusion implants was also performed in accordance with the following standards:
- . AAMI TIR12
- · ANSI AAMI ST79
- ISO 17655-1 .
- AAMI TIR 39 · .
Testing consisted of steam sterilization testing which confirmed that the non-sterile devices achieved a SAL of 10-8 when exposed to a steam sterilization cycle meeting the recommended cycle parameters outlined in AAMI ANSI ST79.
Clinical Testing:
Clinical testing was not required to demonstrate substantial equivalence.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 2 4 2012
LDR Spine USA, Incorporated % Mr. Bradley Strasser Regulatory Affairs Project Manager 13785 Research Boulevard, Suite 200 Austin. Texas 78750
Re: K121103
Trade Name: LDR Spine USA EasySpine® Posterior Spinal System, LDR Spine USA MC+™ Implant System, LDR Spine USA ROI® Implant system, LDR Spine USA ROI-A® Implant system, LDR Spine USA ROI-C® Implant system, LDR Spine USA ROI-T® Implant system Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH, KWP, MAX, ODP, OVD, OVE, MQP Dated: July 24, 2012 Received: July 25, 2012
Dear Mr. Strasser:
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.
4
Page 2- Mr. Bradley Strasser
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours. Mark N. Melkerson Director
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K121103
LDR Spine USA EasySpine® Posterior Spinal System Device Name:
Indications for Use:
The Easyspine® Posterior Spinal System is a posterior, non-cervical pedicle and non-pedicle system 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 of the thoracic, lumbar and sacral spine:
- 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 .
- Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
- Tumor
- Pseudoarthrosis
- Failed previous fusion
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Div/sion Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KIZ 1103 510(k) Number_
6
510(k) Number (if known):
Device Name:
LDR Spine USA MC+ ™ Implant System
Indications for Use:
When used as an intervertebral body fusion device, the MC+ Implant System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment prior to treatment with the device. The MC+ Implant System is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation is required to properly utilize this system.
When used as a vertebral body replacement device. the MC+ Implant System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system. These devices are intended to be used with autograft or allograft bone.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR :
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices
K121103 510(k) Number_
7
510(k) Number (if known): ({ | 2 ll 0 3
LDR Spine USA ROI® Implant System Device Name:
Indications for Use:
The RO! Partial Vertebral Body Replacement System is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. ROI Partial Vertebral Body Replacement implants may be implanted singularly or in pairs. Supplemental internal fixation is required to properly utilize the system.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Divison Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K12 1103 510(k) Number__
8
510(k) Number (if known): KI2 110 3
LDR Spine USA ROI-A® Implant System Device Name:
Indications for Use:
When used as an intervertebral body fusion device. the ROI-A Implant System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K121103 510(k) Number_
Page 4/6
9
510(k) Number (if known): K121103
LDR Spine USA ROI-C® Implant System Device Name:
Indications for Use:
The RO!-C Implant System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The LDR Spine ROI-C Implant System is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental internal fixation is required to properly utilize this system.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KIZII03 510(k) Number_
Page 5/6
10
510(k) Number (if known): K12 1103
LDR Spine USA ROI-T® Implant System Device Name:
Indications for Use:
When used as an intervertebral body fusion device, the ROI-T Implant System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic The device system is designed for use with supplemental fixation and with studies. autograft to facilitate fusion.
When used as a vertebral body replacement device, the ROI-T Implant System is indicated for use to replace a vertebral body that has been resected or excised due to turnor or trauma/fracture. The device is intended for use as a partial vertebral body replacement in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental fixation. Supplemental internal fixation is required to properly utilize the system. These devices are intended to be used with autograft or allograft bone.
The ROI-T implants may be implanted singularly or in pairs.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K121103 510(k) Number_