(48 days)
Not Found
No
The summary describes a physical implant and surgical instruments, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is an intervertebral body fusion system, which is a structural implant used to stabilize the spine, not to provide therapeutic treatment in the sense of curing a disease or alleviating symptoms through an active biological or physiological effect. It is used as part of a surgical procedure to achieve fusion.
No
Explanation: The provided text describes an interbody fusion system intended for surgical implantation to treat degenerative disc disease and spondylolisthesis. It is a therapeutic device designed for structural stability and fusion, not for diagnosing medical conditions.
No
The device description explicitly states it is comprised of "unitary PEEK interbody cages of various sizes" and includes "instruments provided with the system include osteoteomes, implant trials, and an inserter". These are physical hardware components, not software.
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 device is for intervertebral body fusion of the lumbar spine. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as an interbody cage system comprised of implants and instruments for placement. These are physical devices used in surgery.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (like blood, urine, or tissue) or to provide diagnostic information about a patient's condition. Its purpose is to provide structural support and facilitate fusion.
- Performance Studies: The performance studies mentioned are related to the mechanical properties of the implant (compression, subsidence), not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The PrimaLIFTM LLIF system does not fit this description.
N/A
Intended Use / Indications for Use
The OSTEOMED PrimaLIFTM LLIF is indicated for intervertebral body fusion of the lumbar spine to be used with autogenous bone graft, 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 level or two contiguous levels for the treatment of degenerative disc disease (DDD) and these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation systems such as PrimaLOKTM SP and PrimaLOKTM FF which have been cleared for use in the lumbar spine.
The PrimaLIFTM LLIF implants are intended for single use only.
Product codes
MAX
Device Description
The PrimaLIFTM LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System is a comprehensive interbody cage system that provides structural stability of the anterior column. It is comprised of unitary PEEK interbody cages of various sizes. The instruments provided with the system include osteoteomes, implant trials, and an inserter to facilitate placement of the interbody device.
Mentions image processing
Tantalum markers inserted for visibility with imaging as described by ASTM F560-08.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine, L2 to S1
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The PrimaLIF™ LLIF device has been tested in static and dynamic axial compression per ASTM F2077 and static subsidence per ASTM F2267. The intended use of the device is the same as the predicate devices. Clinical testing is not required to support substantial equivalence.
In conclusion, the device is safe and effective and performs as well as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the word "OSTEOMED" in bold, black letters. The word is inside of a black oval shape. The oval shape is slightly tilted upwards.
510(k) Summary
| Submitter Information: | OsteoMed
3885 Arapaho Road
Addison, Texas 75001
Phone: (972) 677-4600
Fax: (972) 677-4601 | NOV 2 9 2012 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Mrs. Piedad Peña | |
| Date Prepared: | November 21, 2012 | |
| Device Information: | | |
| Proposed Trade Name: | OsteoMed Spine PrimaLIF™ LLIF Unitary
PEEK Lateral Lumbar Interbody Fusion System | |
| Classification Name: | Intervertebral body fusion device | |
| Regulation Number: | 21 CFR 888.3080 | |
| Device Product Code: | MAX | |
| Device Class: | Class II | |
| Predicate Devices: | | |
| Lanx Fusion System - Lateral (K103666) | | |
Classification Name: Orthosis, spinal intervertebral fusion (21 CFR 888.3080 Product Code: MAX)
Device Class: II
DePuy Lumbar I/F Cage with VSP Spine System (P960025)
Classification Name: Intervertebral Fusion Device with Bone Graft, lumbar (21 CFR 888.3080 Product Code: MAX)
Device Class: II
Synthes Oracle Spacer (K072791)
Classification Name: Spinal Intervertebral Body Fusion (21 CFR 888.3080 Product Code: MAX)
Device Class: II
Device Description:
The PrimaLIFTM LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System is a comprehensive interbody cage system that provides structural stability of the anterior column. It is comprised of unitary PEEK interbody cages of various sizes. The instruments provided with the system include osteoteomes, implant trials, and an inserter to facilitate placement of the interbody device.
Materials:
The device is made of PEEK (poly-ether-ketone) manufactured from Invibio PEEK OPTIMA® LT1 as described by ASTM F 2026-08 with Tantalum markers inserted for visibility with imaging as described by ASTM F560-08.
OsteoMed 3885 Arapaho Road Addison, Texas 75001 (972) 677-4600 FAX: (800) 390-2620 Customer Service: (800) 456-7779
COLSON ASSOCIATE
1
Image /page/1/Picture/1 description: The image shows the word "OSTEOMED" in bold, black letters. The word is surrounded by a black, oval shape that is thicker on the sides and thinner on the top and bottom. The logo is simple and modern, with a focus on the company name.
The instrumentation is made from various grades of chrome coated stainless steel, anodized aluminum, and/or medical grade silicone.
Intended Use:
The OSTEOMED PrimaLIFTM LLIF is indicated for intervertebral body fusion of the lumbar spine to be used with autogenous bone graft, 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 level or two contiguous levels for the treatment of degenerative disc disease (DDD) and these patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation systems such as PrimaLOKTM SP and PrimaLOKTM FF which have been cleared for use in the lumbar spine.
The PrimaLIFTM LLIF implants are intended for single use only.
Technological Characteristics:
The predicate devices consist of interverterbal body fusion devices designed with wedge shaped noses, serrations or teeth at endplate contacting surfaces, and central cavities to hold bone graft along with instrumentation for facilitating placement of the device using a direct lateral approach. The OsteoMed PrimaLIFTM LLIF device also is designed with wedge shaped noses, serrations or teeth at endplate contacting surfaces, and central cavities to hold bone graft along with instrumentation for facilitating placement of the device using a direct lateral approach.
Material used for the PrimaLIF™ LLIF is the same as the Lanx Lateral and Synthes Oracle Spacer predicate devices, PEEK OPTIMA® LT1 as described by ASTM F 2026-08. This material is biocompatible.
Performance/Clinical Data:
The PrimaLIF™ LLIF device has been tested in static and dynamic axial compression per ASTM F2077 and static subsidence per ASTM F2267. The intended use of the device is the same as the predicate devices. Clinical testing is not required to support substantial equivalence.
In conclusion, the device is safe and effective and performs as well as the predicate devices.
OsteoMed 3885 Arapaho Road Addison, Texas 75001 (973) 677-4600 FAX: (800) 390-2620 Customer Service: (800) 456-7779
Image /page/1/Picture/13 description: The image shows a logo with the word "Colson" in a stylized font on the left, and the words "A COLSON ASSOCIATE" in a smaller, sans-serif font on the right. The word "Colson" is enclosed in a circular shape. The logo appears to be for a company or organization called "Colson Associate".
2
K123207 Page 3 of 3
Image /page/2/Picture/1 description: The image shows the logo for Osteomed. The logo consists of the word "OSTEOMED" in bold, sans-serif font, with the letters slightly slanted to the right. The word is enclosed within a horizontally stretched oval shape, with the top and bottom lines of the oval curving around the word. There is a small dot above and to the right of the letter "D".
Substantial Equivalence:
The basis of substantial equivalence for this device is based on similarities in intended use, anatomic location, mechanical properties and method of stabilization to the predicate devices including the Lanx Lateral (K103666), the DePuy Lumbar I/F Cage (P960025), and the Synthes Oracle Spacer (K072791), based on their promotional materials, labeling and FDA clearance letters. Also, the basis of substantial equivalence for this device is based on similarities in material of manufacture to the Lanx Lateral (K103666) and the Synthes Oracle Spacer (K072791) based on their promotional materials, labeling and FDA clearance letters.
Due to the similarity of materials and design to the predicate devices, OsteoMed believes that the PrimaLIFTM LLIF device does not raise any new safety or effectiveness issues and performs as well as the predicate devices.
OsteoMed 3885 Arapaho Road Addison, Texas 75001 974) 677-4600 FAX: (800) 390-2620 Customer Service: (800) 456-7779
Image /page/2/Picture/6 description: The image shows the logo for A Colson Associate. The logo consists of the word "Colson" in a stylized font, with a vertical line extending from the top of the "l". To the right of the word "Colson" is the text "A COLSON ASSOCIATE" in a smaller, sans-serif font. The logo is simple and professional, and it is likely used to represent a business or organization.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 29, 2012
OsteoMed LP % Piedad Peña, M.S. Manager, Regulatory Affairs 3885 Arapaho Road Addison, Texas 75001
Re: K123207
Trade/Device Name: PrimaLIFTM LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: October 11, 2012 Received: October 12, 2012
Dear Ms. Peña:
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
4
Page 2 - Piedad Peña, M.S.
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/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.
Ronald P. Jean for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K123207
Device Name: PrimaLIF™ LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System Indications for Use:
The PrimaLIFTM LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System (PrimaLIFTM LLIF) is indicated for intervertebral body fusion of the lumbar spine to be used with autogenous bone graft, 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 level or two contiguous levels for the treatment of degenerative disc disease (DDD) and these patients may have up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation systems such as PrimaLOK™ SP and PrimaLOK™ FF which have been cleared for use in the lumbar spine.
The PrimaLIFTM LLIF implants are intended for single use only.
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)
Ronald P. Jean
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123207