(159 days)
Not Found
No
The summary describes a mechanical implant for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is described as an implantable system intended for intervertebral body fusion of the spine to treat degenerative disc disease, which clearly indicates a therapeutic purpose.
No
Explanation: The provided text describes the ShurFit Lumbar Interbody System as an implantable device used for intervertebral body fusion. Its purpose is to provide mechanical support and facilitate fusion, not to diagnose a condition.
No
The device description clearly states that the system consists of implants made from physical materials (Ti-6Al-4V ELI, PEEK Optima, Titanium, Hydroxyapatite, Tantalum) and is intended to provide mechanical support. This indicates a hardware-based medical device, not a software-only one.
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 about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The ShurFit Lumbar Interbody System is an implantable medical device designed to be surgically placed in the spine to facilitate fusion. It is a physical structure made of materials like titanium or PEEK.
- Intended Use: The intended use is to provide mechanical support and facilitate bone fusion in the lumbar spine for patients with degenerative disc disease. This is a therapeutic intervention, not a diagnostic one based on analyzing bodily specimens.
The provided text clearly describes a surgical implant, not a device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
The ShurFit Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space for the ALIF, LLIF, TLIF and T-PLIF system. Two devices are used per intervertebral space for the PLIF system.
The ShurFit Lumbar Interbody System (ALIF, LLIF, TLIF, T-PLIF and PLIF Systems) is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with supplemental fixation and autogenous autograft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.
Product codes
MAX
Device Description
The ShurFit® Lumbar Interbody System consists of implants with various widths, heights, and lengths to accommodate individual patient anatomy and graft material size. The ShurFit® Lumbar Interbody System implants are offered as PLIF (straight), T-PLIF (oblique), TLIF (curved). ALIF. and LLIF. The implants are to be packed with autogenous bone graft to facilitate fusion. The devices are intended to provide mechanical support to the implanted level until biologic fusion is achieved. All components are manufactured either from additive Ti-6Al-4V ELI per ASTM F3001 or from medical grade polyetheretherketone (PEEK Optima, LT1) per ASTM F2026 with or without a coating of Commercially Pure Titanium per ASTM F1580 and Hydroxyapatite per ASTM F1185. PEEK implants contain tantalum markers per ASTM F560. The PEEK implants are provided non-sterile with sterilization instructions; the titanium alloy and the PEEK coated implants are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Lumbar spine, from L2 to S1
Indicated Patient Age Range
skeletally mature patients
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 ShurFit® Lumbar Interbody System Implants have been tested in the following test modes:
- Static and dynamic axial compression per ASTM F2077 .
- Static and dynamic compression shear per ASTM F2077
- Subsidence per ASTM F2267 ●
The results of this non-clinical testing show that the strength of the ShurFit® Lumbar Interbody System Implants is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K171657, K092193, K081196, K080314, K172341, K181589, K162496, K180963, K201024
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 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.
December 8, 2021
Precision Spine, Inc. % Nathan Wright, MS Engineer and Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K212075
Trade/Device Name: ShurFit® Lumbar Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: November 8, 2021 Received: November 9, 2021
Dear Nathan 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.
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
1
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 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. 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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name ShurFit® Lumbar Interbody System
Indications for Use (Describe)
The ShurFit Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space for the ALIF, LLIF, TLIF and T-PLIF system. Two devices are used per intervertebral space for the PLIF system.
The ShurFit Lumbar Interbody System (ALIF, LLIF, T-PLIF and PLIF Systems) is intended for use at ether one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with supplemental fixation and autogenous autograft. Patients should have at least six months of non-operative treatment with a lumbar intervertebral fusion device.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| Submitter's Name: | Precision Spine, Inc. | |
|---|---|---|
| Submitter's Address: | 2050 Executive Dr. | |
| Pearl, MS 39208 | ||
| Submitter's Telephone: | 601-420-4244 | |
| Contact Person: | Nathan Wright MS | |
| Empirical Testing Corp. | ||
| 1-719-351-0248 | ||
| nwright@empiricaltech.com | Image: Empirical Testing Corp. logo | |
| Date Summary was Prepared: | July 1, 2021 | |
| Trade or Proprietary Name: | ShurFit® Lumbar Interbody 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: | Orthopedic |
510(K) SUMMARY
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The ShurFit® Lumbar Interbody System consists of implants with various widths, heights, and lengths to accommodate individual patient anatomy and graft material size. The ShurFit® Lumbar Interbody System implants are offered as PLIF (straight), T-PLIF (oblique), TLIF (curved). ALIF. and LLIF. The implants are to be packed with autogenous bone graft to facilitate fusion. The devices are intended to provide mechanical support to the implanted level until biologic fusion is achieved. All components are manufactured either from additive Ti-6Al-4V ELI per ASTM F3001 or from medical grade polyetheretherketone (PEEK Optima, LT1) per ASTM F2026 with or without a coating of Commercially Pure Titanium per ASTM F1580 and Hydroxyapatite per ASTM F1185. PEEK implants contain tantalum markers per ASTM F560. The PEEK implants are provided non-sterile with sterilization instructions; the titanium alloy and the PEEK coated implants are provided sterile.
INDICATIONS FOR USE
The ShurFit Lumbar Interbody System is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space for the ALIF, LLIF, TLIF and T-PLIF system. Two devices are used per intervertebral space for the PLIF system.
The ShurFit Lumbar Interbody System (ALIF, LLIF, TLIF, T-PLIF and PLIF Systems) is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with supplemental fixation and
Precision Spine, Inc. ShurFit® Lumbar Interbody System
4
autogenous autograft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.
TECHNOLOGICAL CHARACTERISTICS
The subject and predicate devices have nearly identical 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 .
- Technological characteristics
- Materials of manufacture ●
- Range of Sizes
Predicate Devices
| 510k Number | Trade or Proprietary or
Model Name | Manufacturer | Product Code | Predicate
Type |
|------------------------------|-------------------------------------------------|-------------------------------------------|--------------|-------------------|
| K171657 | ShurFit 2C Lumbar
Interbody Fusion System | Precision Spine, Inc. | MAX | Primary |
| K092193, K081196,
K080314 | Spinal USA Intervertebral
Body Fusion Device | Spinal USA (now Precision
Spine, Inc.) | MAX | Additional |
| K172341 | NuVasive® Modulus TLIF
Interbody System | NuVasive, Inc. | MAX | Additional |
| K181589 | Curiteva Lumbar Interbody
System | Curiteva, LLC | MAX | Additional |
| K162496 | Foundation™ 3D Interbody | CoreLink, LLC | MAX | Additional |
| K180963 | ROCCIA TLIF | Silony Medical GmbH | MAX, PHM | Additional |
| K201024 | Expandable Titanium
PLIF/TLIF System | Spectrum Spine, LLC | MAX | Additional |
PERFORMANCE DATA
The ShurFit® Lumbar Interbody System Implants have been tested in the following test modes:
- Static and dynamic axial compression per ASTM F2077 .
- Static and dynamic compression shear per ASTM F2077
- Subsidence per ASTM F2267 ●
The results of this non-clinical testing show that the strength of the ShurFit® Lumbar Interbody System Implants 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 ShurFit® Lumbar Interbody System Implants are substantially equivalent to the predicate devices.