(90 days)
Not Found
No
The description focuses on the mechanical design and materials of the interbody fusion devices and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is used to treat degenerative disc disease, tumor, or trauma/fracture by replacing or fusing vertebral bodies, which directly addresses a medical condition.
No
Explanation: The device is described as an intervertebral body fusion device and a vertebral body replacement device, which are implantable medical devices used for structural support and fusion, not for diagnosing conditions.
No
The device description clearly outlines physical implants made of PEEK and titanium alloy, which are hardware components. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to replace or fuse vertebral bodies in the spine. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical characteristics of the implants (blocks, teeth, slots, materials) and how they are used for structural support and fixation within the body. This aligns with a surgical implant.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide information about a patient's health status based on in vitro testing.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a physical implant used in a surgical procedure.
N/A
Intended Use / Indications for Use
When used as an intervertebral body fusion device, the LDR Spine Cervical Interbody Fusion System (ROI-C and MC+ devices) 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 Cervical Interbody Fusion System implants are 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 a vertebral body replacement device, the ROI-C and MC+ implants are 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.
Product codes
ODP, MQP
Device Description
ROI-C
ROI-C consists of 'D' shaped blocks in a variety of heights and length x width configurations, and features an enclosed graft space. Lateral rows of teeth are present on both the caudal and cephalic surfaces of the device. The flat of the 'D' shape represents the anterior most portion of the device, and includes features for attachment to instrumentation for insertion, and the slots for the anchors.
The D-shaped ROI-C PEEK implants (PEEK OPTIMA LT1) feature two slots which allow for use with specially designed (and optional) supplemental fixation - the ROI-C Anchoring Plate. The Anchoring Plate, made of titanium alloy (TiAl6V4) can be inserted to obtain fixation to the vertebral bone, by locking in place to the PEEK implant via Locking Tabs.
MC+
MC+ consists of 'D' shaped blocks in a variety of heights and length x width configurations, and features an open or enclosed graft space design. Lateral rows of teeth are present on both the caudal and cephalic surfaces of the device. The flat of the 'D' shape represents the anterior most portion of the device, and includes features for attachment to instrumentation for insertion, and the slots for the Anchoring Clip.
MC+ is intended to be used with supplemental internal fixation (i.e. anchoring clips). MC+ is designed for use with one Anchor Clip. The mechanism by which the Anchoring Clip locks into the MC+ device is achieved via the mating slot in the anterior face and the anti-backout tabs of the Anchoring Clip itself.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine (C2-T1), Thoracolumbar spine (T1-L5)
Indicated Patient Age Range
Skeletally mature 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
Mechanical test results demonstrate that the proposed LDR Spine Cervical Interbody Fusion System is substantially equivalent to the predicate device. Testing was performed in accordance with ASTM F2077 and ASTM F2267.
Key Metrics
Not Found
Predicate Device(s)
BAK/C (P980048), Affinity Cage System (P000028), ROI-C VBR (K083857), MC+ Partial VBR (K043479)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
LDR Spine Cervical Interbody Fusion System (ROI-C and MC+ devices)
510(k) Summary of Safety and Effectiveness
JUL 1 4,2009
| SUBMITTED BY | LDR Spine USA
4030 W. Braker Lane, Suite 360
Austin, TX 78759 |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FOREIGN ESTABLISHMENT
REGISTRATION NUMBER | 3004788213 |
| US AGENT ESTABLISHMENT
REGISTRATION NUMBER | 3004903783 |
| CONTACT PERSON | Noah Bartsch
Manager, Clinical, Regulatory and Quality Affairs
Phone: 512-344-3319
Fax: 512-344-3350 |
| SUBMISSION PREPARED BY | Lisa Peterson
QA Consulting, Inc.
Phone: 512-507-0746 |
| DATE PREPARED | July 13, 2009 |
| CLASSIFICATION NAME | ODP 888.3080 - Intervertebral Fusion Device with
Bone Graft, Cervical |
| COMMON NAME | Intervertebral Body Fusion Device (ODP)
Spinal Vertebral Body Replacement Device (MQP) |
| PROPRIETARY NAME | LDR Spine Cervical Interbody Fusion System |
| PREDICATE DEVICE(S) | Predicate devices include several recently down
classified cages, as well as cleared VBR systems:
- BAK/C (P980048, Zimmer Spine, Approved
4/20/01) - Affinity Cage System (P000028, Medtronic,
Approved 6/13/02) - ROI-C VBR (K083857, LDR Spine, Cleared
2/12/09) - MC+ Partial VBR (K043479, LDR Spine,
Cleared 6/30/05) |
1
SUBSTANTIAL EQUIVALENCE
The LDR Spine Cervical Interbody Fusion System was determined to be substantially equivalent to several commercially available systems.
DEVICE DESCRIPTION
ROI-C
ROI-C consists of 'D' shaped blocks in a variety of heights and length x width configurations, and features an enclosed graft space. Lateral rows of teeth are present on both the caudal and cephalic surfaces of the device. The flat of the 'D' shape represents the anterior most portion of the device, and includes features for attachment to instrumentation for insertion, and the slots for the anchors.
The D-shaped ROI-C PEEK implants (PEEK OPTIMA LT1) feature two slots which allow for use with specially designed (and optional) supplemental fixation - the ROI-C Anchoring Plate. The Anchoring Plate, made of titanium alloy (TiAl6V4) can be inserted to obtain fixation to the vertebral bone, by locking in place to the PEEK implant via Locking Tabs.
MC+
MC+ consists of 'D' shaped blocks in a variety of heights and length x width configurations, and features an open or enclosed graft space design. Lateral rows of teeth are present on both the caudal and cephalic surfaces of the device. The flat of the 'D' shape represents the anterior most portion of the device, and includes features for attachment to instrumentation for insertion, and the slots for the Anchoring Clip.
MC+ is intended to be used with supplemental internal fixation (i.e. anchoring clips). MC+ is designed for use with one Anchor Clip. The mechanism by which the Anchoring Clip locks into the MC+ device is achieved via the mating slot in the anterior face and the anti-backout tabs of the Anchoring Clip itself.
INDICATIONS:
When used as an intervertebral body fusion device, the LDR Spine Cervical Interbody Fusion System (ROI-C and MC+ devices) 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 Cervical Interbody Fusion System implants are 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 a vertebral body replacement device, the ROI-C and MC+ implants are 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.
Page 2 of 3
2
MECHANICAL TEST DATA
Mechanical test results demonstrate that the proposed LDR Spine Cervical Interbody Fusion System is substantially equivalent to the predicate device. Testing was performed in accordance with ASTM F2077 and ASTM F2267.
.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
JUL 1 4 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
LDR Spine USA % Mr. Noah Bartsch, M.S., R.A.C. Manager, Clinical, Regulatory & Quality Affairs 4030 W. Braker Lane, Suite 360 Austin, TX 78759
Re: K091088
Trade/Device Name: LDR Spine Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MQP Dated: April 12, 2009 Received: April 15, 2009
Dear Mr. Bartsch:
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.
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 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.
4
Page 2 - Mr. Noah Bartsch, M.S., R.A.C.
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/CDRH0ffices/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/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Charlyne Vuchnich
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
LDR Spine Cervical Interbody Fusion System
Indications for Use:
When used as an intervertebral body fusion device, the LDR Spine Cervical Interbody Fusion System (ROI-C and MC+ devices) 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 Cervical Interbody Fusion System implants are 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 a vertebral body replacement device, the ROI-C and MC+ implants are 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 (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)
(EXT for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
1088 510(k) Number_K09