(75 days)
InterContinental® Plate-Spacer (K103382)
No
The summary describes a physical interbody fusion device and its materials, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is intended to treat degenerative disc disease and provide structural stability following discectomy, which are therapeutic functions.
No
The device is an interbody fusion device designed for structural support in spinal fusion surgery, not for diagnosing medical conditions.
No
The device description clearly states it is a physical interbody fusion device made from polymer and titanium alloy, intended for surgical implantation. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The INDEPENDENCE® Spacer is a physical implant designed to be surgically placed within the lumbosacral spine to provide structural support and facilitate bone fusion. It is a medical device used in vivo (within the body), not in vitro (in a lab).
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease by implanting the device into the spine.
The information provided describes a surgical implant, not a diagnostic test performed on bodily fluids or tissues.
N/A
Intended Use / Indications for Use
The INDEPENDENCE® Spacer is a stand-alone interbody fusion device 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). The INDEPENDENCE® Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws, which accompany the implant.
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
The INDEPENDENCE® Spacer is a stand-alone anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material. The INDEPENDENCE® Spacer is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295. The screws are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.
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 (expulsion) was conducted to demonstrate substantial equivalence to the predicate device in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Body Fusion Device", June 12, 2007.
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.
INDEPENDENCE® Spacer (K082252)
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.
InterContinental® Plate-Spacer (K103382)
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
§ 888.3080 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
MAR 2 7 2012
510(k) SUMMARY: INDEPENDENCE®SPACER
Globus Medical Inc. Company: 2560 General Armistead Avenue Audubon, PA 19403 (610) 930-1800
Contact: Meriam Youssef Project Manager, Regulatory Affairs
Date Prepared: January 11, 2012
Device Name: INDEPENDENCE® Spacer
Classification: Per 21 CFR as follows: §888.3080 Intervertebral Body Fusion Device Product Code: OVD Regulatory Class II, Panel Code: 87
INDEPENDENCE® Spacer (K082252) Predicate(s): InterContinental® Plate-Spacer (K103382)
Purpose:
The purpose of this submission is to request clearance for hydroxyapatite coated (HA) screws, for use with the cleared INDEPENDENCE® Spacer.
Device Description:
The INDEPENDENCE® Spacer is a stand-alone anterior lumbar interbody fusion device used to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to aid in expulsion resistance. Screws are inserted through the anterior titanium portion of the implant into adjacent vertebral bodies for bony fixation. The spacer is to be filled with autogenous bone graft material.
The INDEPENDENCE® Spacer is made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in ASTM F2026, F136, F1295, and F560. The anterior portion of the implant and the mating screws are manufactured from titanium alloy, as specified in ASTM F136 and F1295. The screws are available with or without hydroxyapatite (HA) coating, as specified in ASTM F1185.
Indications for Use:
The INDEPENDENCE® Spacer is a stand-alone interbody fusion device 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
Ps 1of2
1
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). The INDEPENDENCE® Spacer is to be filled with autogenous bone graft material, and is to be used with three titanium alloy screws, which accompany the implant.
120101
Performance Data:
Mechanical testing (expulsion) was conducted to demonstrate substantial equivalence to the predicate device in accordance with the "Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Intervertebral Body Fusion Device", June 12, 2007.
Basis for Substantial Equivalence:
The INDEPENDENCE® Spacer has been found to be substantially equivalent to the predicate with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence to the predicate device.
Pg 1 of 2
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Globus Medical, Inc. % Ms. Meriam Youssef Project Manager, Regulatory Affairs 2560 General Armistead Ave. Audobon, Pennsylvania 19403
Re: K120101
Trade/Device Name: INDEPENDENCE Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD Dated: March 2, 2012 Received: March 5, 2012
Dear Ms. Youssef:
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
MAR 2 7 2012
3
Page 2 - Ms. Meriam Youssef
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. product rainances version of 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/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Q/K
'~
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
(120/01
Indications for Use Statement
510(k) Number:
Device Name:
INDEPENDENCE® Spacer
Indications:
The INDEPENDENCE® Spacer is a stand-alone interbody fusion device intended The INDEFENDENOE openerative disc disease (DDD) at one on bo contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as contiguous fevels of the lambecation of the disc confirmed by history and discogenic back pain with degone while be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The nave up to Grade T spondyollathesis of retrollethed. In a be graft material and INDER ENDENOE - Spacer is to a low screws, which accompany the implant.
Prescription Use (Per 21 CFR §801.109) OR
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)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KIZDIO I 510(k) Number_