(85 days)
Not Found
No
The summary describes a mechanical expandable interbody fusion device and its inserter, with no mention of AI or ML technology in its function, design, or intended use. The submission focuses on modifications to the inserter and performance testing related to these mechanical changes.
Yes
The device is described as a "lumbar intervertebral body fusion device" used for patients with degenerative disc disease, which aims to fuse spinal segments and alleviate symptoms. This aligns with the definition of a therapeutic device as it directly treats a medical condition.
No.
The device is described as an "Expandable Interbody Device" and is used for "lumbar intervertebral body fusion," which indicates it is a therapeutic or surgical implant rather than a diagnostic tool. Its function is to treat degenerative disc disease, not to diagnose it.
No
The device description explicitly details a physical inserter fabricated from stainless steel, which is a hardware component. The submission focuses on modifications to this hardware.
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 for spinal fusion, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details a surgical instrument (inserter) used to manipulate and implant a spinal fusion device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, or any other components typically associated with in vitro diagnostics.
The device is a surgical implant and its associated instrumentation.
N/A
Intended Use / Indications for Use
The CONCORDE LIFT Expandable Interbody Device is a lumbar intervertebral body fusion device, and is indicated for use with autogenous bone graft and/or allograft comprised of cancellous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine, L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The CONCORDE LIFT Expandable Interbody Device can be implanted via posterior, transforaminal or lateral approach.
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had a six-month course of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.
The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
Product codes
MAX
Device Description
The CONCORDE LIFT Inserter is temporarily attached to the CONCORDE LIFT Expandable Interbody Fusion Device for implantation. A component of the CONCORDE LIFT Inserter, the driver, is then used to increase or decrease the height of the CONCORDE LIFT Expandable Interbody Fusion Device. The CONCORDE LIFT Inserter is intended to be used in conjunction with all sizes of the CONCORDE LIFT Expandable Interbody Device. The Inserter is fabricated from 17-4 PH Stainless Steel and 465 Stainless Steel that meets the requirements of ASTM F899. The inserter is provided non-sterile and is reusable.
The purpose of this submission is to capture the modifications made to the CONCORDE LIFT Expandable Interbody System Inserter.
Mentions image processing
Not Found
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
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 minor modification to the design of the device and material change do not change the technological characteristics of the device. The design modification is supported by the results of feasibility testing.
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.
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February 8, 2018
Medos International, SARL % Desiree Saracino Regulatory Affairs Specialist DePuy Synthes 325 Paramount Drive Raynham, Massachusetts 02767
Re: K173537
Trade/Device Name: CONCORDE LIFT™ Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 13, 2017 Received: November 16, 2017
Dear Ms. Saracino:
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 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);
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1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vincent J. Devlin -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name CONCORDE LIFT™
Indications for Use (Describe)
The CONCORDE LIFT Expandable Interbody Device is a lumbar intervertebral body fusion device, and is indicated for use with autogenous bone graft and/or allograft comprised of cancellous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine, L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The CONCORDE LIFT Expandable Interbody Device can be implanted via posterior, transforaminal or lateral approach.
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had a six-month course of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.
The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------ | ------------------------------------------------------------ |
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K173537 Page 1 of 3
510(k) Summary
Submitter Information A. 510(k) Sponsor: Medos International, SARL Contact Person: Desiree Saracino DePuy Synthes 325 Paramount Drive Raynham, MA 02767 Telephone number: (508) 977-3842 Fax number: (508) 828-3797 Dsaracin@its.jnj.com Email: B. Date Prepared November 13, 2017 C. Device Name CONCORDE LIFT™ Trade/Proprietary Name: Common/Usual Name: Intervertebral Body Fusion Device Device Classification Class II per 21 CFR § 888.3080 and Regulation: Classification Product and Panel Code: MAX; Orthopedic D. Predicate Device Name
K171425: CONCORDE LIFT™ Expandable Interbody Fusion Device Primary:
E. Device Description
The CONCORDE LIFT Inserter is temporarily attached to the CONCORDE LIFT Expandable Interbody Fusion Device for implantation. A component of the CONCORDE
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LIFT Inserter, the driver, is then used to increase or decrease the height of the CONCORDE LIFT Expandable Interbody Fusion Device. The CONCORDE LIFT Inserter is intended to be used in conjunction with all sizes of the CONCORDE LIFT Expandable Interbody Device. The Inserter is fabricated from 17-4 PH Stainless Steel and 465 Stainless Steel that meets the requirements of ASTM F899. The inserter is provided non-sterile and is reusable.
The purpose of this submission is to capture the modifications made to the CONCORDE LIFT Expandable Interbody System Inserter.
F. Indications for Use
The CONCORDE LIFT Expandable Interbody Device is a lumbar intervertebral body fusion device, and is indicated for use with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine, L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The CONCORDE LIFT Expandable Interbody Device can be implanted via posterior, transforaminal or lateral approach.
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had a six-month course of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.
The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.
G. Summary of Similarities and Differences in Technological Characteristics, Performance and Intended Use
The technological characteristics, including material, design and performance of the CONCORDE LIFT Inserter are consistent with those of the predicate devices.
H. Materials
The CONCORDE LIFT Inserter is manufactured from 17-4 PH Stainless Steel, and 465 Stainless Steel that meets the requirements of ASTM F899.
I. Performance Data
The minor modification to the design of the device and material change do not change the technological characteristics of the device. The design modification is supported by the results of feasibility testing.
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K173537 Page 3 of 3
J. Conclusion
Based on the indications for use, technological characteristics, and comparison to the predicate device, the CONCORDE LIFT Inserter is substantially equivalent to the legally marketed predicate device.
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