(60 days)
Not Found
No
The description focuses on the material, design, and mechanical properties of a physical implant for spinal fusion, with no mention of software, algorithms, or data processing.
Yes
The device is intended for spinal fusion procedures to treat degenerative disc disease, which involves addressing a medical condition and promoting healing.
No
Explanation: The device is an intervertebral body fusion device used in spinal fusion procedures, not for diagnosing medical conditions. It is a treatment device, not a diagnostic one.
No
The device description clearly states the device is an implant manufactured from Titanium Alloy, which is a physical hardware component, not software.
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 taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the PLATEAU-A Ti and Plateau-X Ti are "intervertebral body fusion devices" and "spacers" made of titanium alloy. These are implants designed to be surgically placed within the body.
- Intended Use: The intended use is for "spinal fusion procedures" in patients with degenerative disc disease. This involves a surgical intervention, not a diagnostic test performed on a sample outside the body.
The device is a surgical implant used for treatment, not a diagnostic tool used to analyze biological samples.
N/A
Intended Use / Indications for Use
The PLATEAU-A Ti Anterior Lumbar Spacer is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of nonoperative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.
The Plateau-X Ti Lateral Lumbar Spacer is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of nonoperative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX
Device Description
The PLATEAU-A Ti Anterior Lumbar Spacer implants are intervertebral body fusion devices comprised of a variety of spacer implants manufactured from Titanium Alloy (Ti-6A1-4V ELI per ASTM F136). The spacers are hollow to permit packing autograft bone graft and/or allogeneic bone composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to help prevent rotation and/or migration. The implants are available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the PLATEAU-A Ti Anterior Lumbar Spacer components with components from any other system or manufacturer. The components should never be reused under any circumstances.
The Plateau-X Ti Lateral Lumbar Spacer is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration. All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Plateau-X Ti components with components from any other system or manufacturer. The components should never be reused under any circumstances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2-S1 (lumbar spine)
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)
Testing according to ASTM F2077 & F2267 included Static axial compression, static expulsion, static subsidence, and dynamic axial compression tests was presented to demonstrate the substantial equivalency of the Life Spine Plateau (K080411/K111569).
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.
Life Spine Plateau (K080411/K111569), Life Spine Plateau Ti (K130630), Life Spine Plateau-X Spacer System (K121116), AlphaTec Holdings Indenti TI Porous Ti Interbody System (K183705), Alpha Tec Holdings Lateral Interbody System (K191311)
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.
Not Found
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 4, 2020
Life Spine, Inc. Angela Batker RA/OA Manager 13951 S. Quality Drive Huntley, Illinois 60142
Re: K201500
Trade/Device Name: Life Spine Plateau®-A Ti Anterior Lumbar Spacer & Plateau®-X Ti Lateral Lumbar Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: June 1, 2020 Received: June 5, 2020
Dear Angela Batker:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Brent Showalter, Ph.D. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201500
Device Name
Life Spine Plateau®-A Ti Anterior Lumbar Spacer & Plateau®-X Ti Lateral Lumbar Spacer
Indications for Use (Describe)
The PLATEAU-A Ti Anterior Lumbar Spacer is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of nonoperative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.
The Plateau-X Ti Lateral Lumbar Spacer is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of nonoperative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral 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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510(k) Summary Plateau®-A Ti Anterior Lumbar Spacer & Plateau®-X Ti Lateral Lumbar Spacer
| Submitted By: | Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Angela Batker
Life Spine, Inc.
13951 S. Quality Drive
Huntley, IL 60142
Telephone: 847-884-6117
Fax: 847-884-6118 |
| Date Prepared: | May 29, 2020 |
| Trade Name: | Life Spine Plateau®-A Ti Anterior Lumbar Spacer & Plateau®-X Ti
Lateral Lumbar Spacer |
| Common Name: | Interbody Fusion Device |
| Classification: | MAX, CFR 888.3080, Class II |
| Primary Predicate: | Life Spine Plateau (K080411/K111569) |
| Secondary Predicate: | Life Spine Plateau Ti (K130630)
Life Spine Plateau-X Spacer System (K121116)
AlphaTec Holdings Indenti TI Porous Ti Interbody System (K183705)
Alpha Tec Holdings Lateral Interbody System (K191311) |
Device Description:
The PLATEAU-A Ti Anterior Lumbar Spacer implants are intervertebral body fusion devices comprised of a variety of spacer implants manufactured from Titanium Alloy (Ti-6A1-4V ELI per ASTM F136). The spacers are hollow to permit packing autograft bone graft and/or allogeneic bone composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral endplates to help prevent rotation and/or migration. The implants are available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient.
All implants are intended for single use only and should not be reused under any circumstances. Do
4
not use any of the PLATEAU-A Ti Anterior Lumbar Spacer components with components from any other system or manufacturer. The components should never be reused under any circumstances.
The Plateau-X Ti Lateral Lumbar Spacer is intended to serve as an intervertebral body fusion device. The implant is available in a range of sizes and footprints to suit the individual pathology and anatomical conditions of the patient. It is fabricated and manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136. The implant allows packing of autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone to help promote fusion. The superior and inferior surfaces have teeth to assist in the interface with the vertebral bodies to prevent rotation and/or migration.
All implants are intended for single use only and should not be reused under any circumstances. Do not use any of the Plateau-X Ti components with components from any other system or manufacturer. The components should never be reused under any circumstances.
Intended Use of the Device:
The PLATEAU-A Ti Anterior Lumbar Spacer is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of non-operative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.
The Plateau-X Ti Lateral Lumbar Spacer is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). It is to be used in patients who have had at least six months of nonoperative treatment. This device is intended to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and a supplemental internal spinal fixation system (e.g., pedicle screw or anterolateral plating system) that is cleared for use in the lumbosacral spine.
Technological Characteristics:
The Life Spine Plateau®-A Ti Anterior Lumbar Spacer & Plateau®-X Ti Lateral Lumbar Spacer is substantially equivalent to the predicate systems in terms of design, materials, indications for use and sizing.
Material:
This submission seeks clearance of a device made from Titanium (Ti-6AI-4V ELI) per ASTM F136. This this is the same material used in the predicate devices.
Performance Data:
5
Testing according to ASTM F2077 & F2267 included Static axial compression, static expulsion, static subsidence, and dynamic axial compression tests was presented to demonstrate the substantial equivalency of the Life Spine Plateau (K080411/K111569).
Substantial Equivalence:
The Life Spine Plateau®-A Ti Anterior Lumbar Spacer & Plateau®-X Ti Lateral Lumbar Spacer was shown to be substantially equivalent to the predicate devices in indications for use, design, function, materials used and mechanical performance.
Conclusion:
The information presented demonstrates the substantial equivalency of the Life Spine Plateaux®-A Ti Anterior Lumbar Spacer & Plateau®-X Ti Lateral Lumbar Spacer.