(226 days)
No
The description focuses on the mechanical design and materials of an expandable interbody fusion device and its associated manual surgical instruments. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is described as an expandable interbody system intended for spinal fusion procedures in patients with degenerative disc disease, providing structural stability and alleviating back pain of discogenic origin. This aligns with the definition of a therapeutic device designed to treat a medical condition.
No
The Xsert™ Lumbar Expandable Interbody System is an implantable device (spacers) used for spinal fusion procedures. Its purpose is to provide structural stability and is packed with bone graft, not to diagnose a condition.
No
The device description clearly states it is an expandable interbody system made of Titanium alloy and includes manual surgical instruments, indicating it is a physical medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue taken from the human body to detect diseases, conditions, or infections.
- Device Description: The Xsert™ Lumbar Expandable Interbody System is a physical implant made of titanium alloy, designed to be surgically inserted into the spine for fusion procedures. It is a medical device used in vivo (within the body), not in vitro (in a lab setting).
- Intended Use: The intended use is for spinal fusion procedures to treat degenerative disc disease, which is a surgical intervention, not a diagnostic test.
The device is a surgical implant, not a diagnostic tool that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Xsert™ Lumbar Expandable Interbody System is intended for spinal fusion procedures at one or two contiguous levels (L2 - S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autograft and/or allogenic bone graft comprised of cancellous bone graft and implanted via a posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The Xsert™ Lumbar Expandable Interbody System of X-spine Systems, Inc. is an expandable interbody system used to provide structural stability in skeletally mature individuals following discectomy. The Xsert™ Lumbar Expandable Interbody System will consist of spacers offered in various shapes and sizes, and their heights can be intra-operatively expanded to fit the anatomical needs of a wide variety of patients. These spacers are intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft material and have features on the superior and inferior surfaces of each device to grip the endplates of the adjacent vertebrae to resist expulsion.
The implant components of the system are manufactured from medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F-136. All implants will be provided clean and sterile, are intended for single use only, and should not be reused under any circumstances.
A series of manual surgical instruments intended to assist with the insertion and placement of the implants is included in an instrument tray, which is used for instrument sterilization and storage.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbosacral spine (L2 - S1 inclusive)
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)
Mechanical testing was performed as follows:
- Static and Dynamic Compression and Compression Shear per ASTM F2077 Test Methods for Intervertebral Body Fusion Devices
- Subsidence per ASTM F2267 Standard Test Method for Measuring Load . Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression.
- Expulsion per FDA Guidance Class II Special Controls Guidance Document: . Intervertebral Body Fusion Device
Simulated Use: Design validation of the Xsert™ Lumbar System components and Surgical Technique Guide was performed with surgeons in a cadaveric laboratory evaluation. The surgeons also performed supplementary evaluations of packing the expandable implants with bone graft.
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.
Globus Medical Caliber Spacers (K102293), X-spine Calix Lumbar Spinal Implant System (K131350), Stryker AccuLIF® TL and PL Cage (K152651), Interventional Spine Opticage Interbody Fusion Device (K113527)
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.
X-spine Pedicle Screw System (K152132)
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
Image /page/0/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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2016
X-spine Systems, Inc. % Kriss Anderson Director, Regulatory Affairs 452 Alexandersville Rd. Miamisburg, Ohio 45342
Re: K160959
Trade/Device Name: Xsert™ Lumbar Expandable Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: September 19, 2016 Received: September 21, 2016
Dear Mr. Anderson:
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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,
Mark N. Melkerson -S
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
Xsert™ Lumbar Expandable Interbody System
Indications for Use (Describe)
The Xsert™ Lumbar Expandable Interbody System is intended for spinal fusion procedures at one or two contiguous levels (L2 - S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autograft and/or allogenic bone graft comprised of cancellous bone graft and implanted via a posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, and anterior screw and rod systems).
| 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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510(K) SUMMARY (21 CFR 807.92)
Xsert™ Lumbar Expandable Interbody System March 31, 2016
l. SUBMITTER/MANUFACTURER:
X-spine Systems, Inc. 452 Alexandersville Rd. Miamisburg, OH 45342
Telephone (937) 847-8400 FAX (937) 847-8410
Establishment Registration Number: 3005031160
Official Contact: Mr. Kriss Anderson Director, Requlatory Affairs Email: kanderson@X-spine.com Telephone (937) 847-8400, ext. 2137
II. OWNER/OPERATOR:
Xtant Medical Inc. 604 Cruiser Lane Belgrade, MT 59714
Xtant Medical, Inc.
Owner/Operator Number: 10028385
Official Correspondent:
lll. DEVICE
Trade/Proprietary Name:
Device Common Name: Requlation Number: Product Code:
Xsert™ Lumbar Expandable Interbody System
Regulatory Assurance/ Quality Assurance
Stephen Smith, Vice President
Telephone (406) 388-0480
Intervertebral Body Fusion Device 21 CFR §888.3080 MAX (888.3080) Intervertebral body fusion device
Review Panel:
Orthopedic
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IV. PREDICATE DEVICES
●
- Primary: Globus Medical Caliber Spacers (K102293) . This predicate has not been subject to a design related recall. O
- Additional: X-spine Calix Lumbar Spinal Implant System (K131350) .
- o This predicate has not been subject to a design related recall.
- Additional: Stryker AccuLIF® TL and PL Cage (K152651) o This predicate has not been subject to a design related recall.
- Additional: Interventional Spine Opticage Interbody Fusion Device (K113527) ●
- This predicate has not been subject to a design related recall. o
V. REFERENCE DEVICE
X-spine Pedicle Screw System (K152132) – grit blasting technology
- o This predicate has not been subject to a design related recall.
INDICATIONS FOR USE VI.
The Xsert™ Lumbar Expandable Interbody System is intended for spinal fusion procedures at one or two contiguous levels (L2 - S1 inclusive) in skeletally mature patients with degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the lumbosacral spine. DDD patients may also have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous non-fusion spinal surgery at the involved level(s). These implants are to be packed with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and implanted via a posterior, and/or transforaminal approach. Patients should receive at least six (6) months of non-operative treatment prior to treatment with a lumbosacral intervertebral fusion device.
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems).
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VII. DEVICE DESCRIPTION
The Xsert™ Lumbar Expandable Interbody System of X-spine Systems, Inc. is an expandable interbody system used to provide structural stability in skeletally mature individuals following discectomy. The Xsert™ Lumbar Expandable Interbody System will consist of spacers offered in various shapes and sizes, and their heights can be intra-operatively expanded to fit the anatomical needs of a wide variety of patients. These spacers are intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft material and have features on the superior and inferior surfaces of each device to grip the endplates of the adjacent vertebrae to resist expulsion.
The implant components of the system are manufactured from medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F-136. All implants will be provided clean and sterile, are intended for single use only, and should not be reused under any circumstances.
A series of manual surgical instruments intended to assist with the insertion and placement of the implants is included in an instrument tray, which is used for instrument sterilization and storage.
VIII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The technological principle for both the subject and predicate devices is posterior, fixation at one or two contiguous levels (L2 - S1 inclusive) for skeletally mature patients with degenerative disc disease of the lumbosacral spine.
At a high level, the subject device, and one or more of the predicate devices identified above are based on the following same or equivalent technological elements:
- FDA Product Code: MAX -- Intervertebral Body Fusion Device O
- Indications for Use. O
- lmplants use the same material: Titanium alloy O
- Multiple sizes to account for variations in patient anatomy. O
- Anatomical region. O
- Surgical approach. O
- Mechanical performance. O
- Sterility of package Sterile, single use implants o
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IX. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Mechanical Testing
Mechanical testing was performed as follows:
- . Static and Dynamic Compression and Compression Shear per ASTM F2077 Test Methods for Intervertebral Body Fusion Devices
- Subsidence per ASTM F2267 Standard Test Method for Measuring Load . Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression.
- Expulsion per FDA Guidance Class II Special Controls Guidance Document: . Intervertebral Body Fusion Device
Simulated Use
Design validation of the Xsert™ Lumbar System components and Surgical Technique Guide was performed with surgeons in a cadaveric laboratory evaluation. The surgeons also performed supplementary evaluations of packing the expandable implants with bone graft.
X. CONCLUSION
Based on a review of the information provided, X-spine finds that the Xsert™ Lumbar Expandable Interbody System is substantially equivalent to the referenced predicate device systems. The Xsert™ Lumbar Expandable Interbody System was found to have an equivalent safety and effectiveness profile compared to the referenced predicate systems.