(145 days)
Not Found
No
The summary describes a mechanical interbody fusion device made of titanium alloy. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes
Explanation: The device is an interbody fusion device intended for use in patients with degenerative disc disease, which aims to treat a medical condition.
No
Explanation: The document clearly states that LATIS™ Spacers are "interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine". These devices are implants designed to provide structural stability and facilitate fusion, not to diagnose medical conditions.
No
The device description clearly states that the LATIS™ Spacers are manufactured from titanium alloy, indicating a physical hardware 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 device is an interbody fusion device used in surgical procedures to treat degenerative disc disease. It is implanted into the body.
- Device Description: The description details a physical implant made of titanium alloy, designed to provide structural stability in the spine.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used outside the body to analyze samples. This device is a surgical implant used inside the body.
N/A
Intended Use / Indications for Use
LATIS™ Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
LATIS™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.
Product codes
MAX
Device Description
LATIS™ Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. LATIS™ Spacers are provided in a shape that accommodates a posterior, transforaminal, or lateral approach to the lumbar spine; after insertion the implant can be transformed to the desired footprint. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
LATIS™ Spacers are manufactured from titanium alloy per ASTM F136 and F1295.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine (L2-S1)
Indicated Patient Age Range
skeletally mature
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)
Mechanical testing consisting of static and dynamic compression, static and dynamic compression-shear, and subsidence was conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate systems.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K072970, K093242, K102313, K111726, K110226
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
K123913 Page 1 of 2
510(k) SUMMARY: LATIS™ Spacers
MAY 1 3 2013
Company: Globus Medical Inc. 2560 General Armistead Ave. Audubon, PA 19403 (610) 930-1800
Contact: Christina Kichula Group Manager, Regulatory Affairs
Date Prepared: December 18, 2012
Device Name: LATIS™ Spacers
Classification: Per 21 CFR as follows: §888.3080 Intervertebral Body Fusion Devices. Product Code: MAX. Regulatory Class II, Panel Code: 87.
PATRIOT® (K072970, K093242, & K102313) Predicate(s): Custom Spine PATHWAY AVID™ Spacers (K111726) Vertebral Technologies Inter-Fuse® T (K110226)
Purpose:
The purpose of this submission is to request clearance for the LATIS™ Spacers a modification of the cleared PATRIOT ® Spacers.
Device Description:
LATIS™ Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. LATIS™ Spacers are provided in a shape that accommodates a posterior, transforaminal, or lateral approach to the lumbar spine; after insertion the implant can be transformed to the desired footprint. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.
LATIS™ Spacers are manufactured from titanium alloy per ASTM F136 and F1295.
Indications for Use:
LATIS™ Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These
1
patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
LATIS™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.
Technological Characteristics:
The technological characteristics of the LATIS™ Spacers are similar to the predicate devices in terms of design, dimensions, intended use, materials, and performance characteristics.
Performance Data:
Mechanical testing consisting of static and dynamic compression, static and dynamic compression-shear, and subsidence was conducted in accordance with "Class II Special Controls Guidance Document: Intervertebral Fusion Device," June 12, 2007, ASTM F2077, and ASTM F2267 to demonstrate substantial equivalence to the predicate systems.
Basis for Substantial Equivalence:
The LATIS™ Spacers are similar to the predicate systems with respect to technical characteristics, performance and intended use. The information provided within this premarket notification supports substantial equivalence of the subject spacers to the predicate devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -- WO66-G609 Silver Spring, MD 20993-0002
Letter dated: May 13, 2013
Globus Medical, Incorporated % Ms. Christina Kichula Group manager, Regulatory Affairs Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403
- Re: K123913
Trade/Device Name: LATISTM Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: December 18, 2012 Received: December 19, 2012
Dear Ms. Kichula:
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
3
Page 2 - Ms. Christina Kichula
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm. 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 Newterson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K123913 Page 1 of 1
Indications for Use Statement
510(k) Number:
Device Name:
LATIS™ Spacer
Indications:
LATIS™ Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
LATIS™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.
OR Prescription Use × (Per 21 CFR §801.109)
Over-The-Counter Use_
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Anton E. Dmitriev, PhD Division of Orthopedic Devices