(374 days)
Not Found
No
The description focuses on the mechanical properties and design of a physical implant for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is an interbody fusion device intended for use in patients with degenerative disc disease, which involves treating a medical condition.
No
This device is an interbody fusion device intended for use in surgical procedures to provide structural stability in the spine, not to diagnose a condition.
No
The device description clearly states it is a system of titanium interbody fusion devices, which are physical implants, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Spectrum Spine Expandable PLIF/TLIF Interbody Cage System is an implantable device used for spinal fusion. It is a physical structure inserted into the body during surgery.
- Intended Use: The intended use is to provide structural stability and facilitate fusion in the lumbosacral spine. This is a surgical intervention, not a diagnostic test performed on a sample.
The information provided describes a surgical implant, not a device used for testing biological samples outside of the body.
N/A
Intended Use / Indications for Use
The Spectrum Spine Expandable PLIF/TLIF Interbody Cage System is an 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 non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Expandable PLIF/TLIF implants are to be filled with autogenous bone graft material. The device are intended to be used with supplemental fixation.
Product codes
MAX
Device Description
The Spectrum Spine Expandable Titanium PLIF/TLIF System consists of lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The Expandable Titanium PLIF/TLIF System implants are provided in various shapes to accommodate posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) surgical approaches. These implants can expand to the desired height and varying degrees of lordosis as appropriate. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Expandable Titanium PLIF/TLIF System is 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. The Expandable Titanium PLIF/TLIF System is manufactured from titanium alloy per ASTM F136. The system provides several footprints in multiple height and angle configurations. The cage's ability to be inserted at a nominal height and then expand in both height and angle to fill the joint space once properly positioned minimizes damage to the bony end-plate caused by impaction.
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
Prescription Use
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
The Expandable Titanium PLIF/TLIF System has been tested in the following test modes: Static axial compression per ASTM F2077, Static compression shear per ASTM F2077, Dynamic axial compression per ASTM F2077, Dynamic compression shear per ASTM F2077, Subsidence per ASTM F2267. The results of this non-clinical testing show that the strength of the Expandable Titanium PLIF/TLIF System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K172696, K080537, K173518, K140411
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
April 29, 2021
Spectrum Spine, LLC % Mr. Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K201024
Trade/Device Name: Expandable Titanium PLIF/TLIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 17, 2021 Received: March 18, 2021
Dear Mr. Wright:
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.
1
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) 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 (QS) 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 medical devices and radiation-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. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.
510(k) Number (if known) K201024 Device Name Expandable Titanium PLIF/TLIF System
Indications for Use (Describe)
The Spectrum Spine Expandable PLIF/TLIF Interbody Cage System is an 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 non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Expandable PLIF/TLIF implants are to be filled with autogenous bone graft material. The device are intended to be used with supplemental fixation.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including
the time to review instructions, search existing data sources, gather and maintain the data needed and
complete and review the collection of information. Send comments regarding this burden estimate or any
other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information
unless it displays a currently valid OMB number."
3
510(K) SUMMARY
| Submitter's Name: | Spectrum Spine, LLC |
|---|---|
| Submitter's Address: | 4020 Stovall Terrace NE |
| Atlanta, GA 30342 | |
| Submitter's Telephone: | 404-550-1335 |
| Contact Person: | Nathan Wright |
| Empirical Testing Corp. | |
| 719-351-0248 | |
| nwright@empiricaltech.com | |
| Date Summary was Prepared: | April 17, 2020 |
| Trade or Proprietary Name: | Expandable Titanium PLIF/TLIF System |
| Common or Usual Name: | Intervertebral Fusion Device with Bone Graft, Lumbar |
| Classification: | Class II per 21 CFR §888.3080 |
| Product Code: | MAX |
| Classification Panel: | Division of Orthopedics |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Spectrum Spine Expandable Titanium PLIF/TLIF System consists of lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The Expandable Titanium PLIF/TLIF System implants are provided in various shapes to accommodate posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) surgical approaches. These implants can expand to the desired height and varying degrees of lordosis as appropriate. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. The Expandable Titanium PLIF/TLIF System is 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.
The Expandable Titanium PLIF/TLIF System is manufactured from titanium alloy per ASTM F136.
The system provides several footprints in multiple height and angle configurations. The cage's ability to be inserted at a nominal height and then expand in both height and angle to fill the joint space once properly positioned minimizes damage to the bony end-plate caused by impaction.
INDICATIONS FOR USE
The Spectrum Spine Expandable PLIF/TLIF Interbody Cage System is an 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 non-operative treatment. In
4
K201024 Page 2 of 2
addition, these patients may have up to Grade 1 spondylolisthesis at the involved level(s). Expandable PLIF/TLIF implants are to be filled with autogenous bone graft material. The device are intended to be used with supplemental fixation.
TECHNOLOGICAL CHARACTERISTICS
The Expandable Titanium PLIF/TLIF System is made from medical grade titanium allov that conforms to ASTM F136. The subject and predicate devices have similar technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:
- . Indications for Use
- Materials of manufacture ●
- Structural support mechanism .
- Surgical Approach .
- . Sizes
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Predicate
Type |
|-------------|---------------------------------------|----------------------|-------------------|
| K172696 | FORZA® XP Expandable
Spacer System | Orthofix Inc. | Primary |
| K080537 | L-Varlock Lumbar Cage | Kiscomedica | Additional |
| K173518 | Spectrum Spine Expandable
Cages | Spectrum Spine, LLC | Additional |
| K140411 | ALTERATM Spacer | Globus Medical, Inc. | Additional |
Table 5-1 Predicate Devices
PERFORMANCE DATA
The Expandable Titanium PLIF/TLIF System has been tested in the following test modes:
- . Static axial compression per ASTM F2077
- . Static compression shear per ASTM F2077
- Dynamic axial compression per ASTM F2077 .
- Dynamic compression shear per ASTM F2077 .
- Subsidence per ASTM F2267 .
The results of this non-clinical testing show that the strength of the Expandable Titanium PLIF/TLIF System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the Expandable Titanium PLIF/TLIF System is substantially equivalent to the predicate device.