(127 days)
No
The 510(k) summary describes a physical interbody fusion device made of PEEK and tantalum markers, with no mention of software, algorithms, or AI/ML capabilities.
Yes.
The device is an intervertebral body fusion device used to treat cervical and lumbar disc disease, aiming to alleviate pain and restore function, classifying it as a therapeutic device.
No
Explanation: The Blustone Synergy implants are intervertebral body fusion devices designed for surgical implantation to aid in spinal fusion, not for diagnosing medical conditions. Their function is therapeutic/restorative, not diagnostic.
No
The device description clearly states that the device is composed of physical implants made of PEEK and tantalum markers. It also describes the physical characteristics and materials of the implants.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Blustone Synergy system is described as an intervertebral body fusion device. Its intended use is to be implanted into the spine to aid in fusion in patients with degenerative disc disease. This is a surgical implant, not a device that analyzes biological samples.
- Lack of IVD Characteristics: The text does not mention any analysis of biological specimens, diagnostic testing, or any function related to providing information about a patient's health status through laboratory analysis.
Therefore, the Blustone Synergy cervical and lumbar implants are medical devices, specifically surgical implants, but they do not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Blustone Synergy cervical (Slate Lavaflow) implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of carcellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative treatment. The Blustone Synergy cervical implants are also to be used with supplemental fixation.
The Blustone Synergy lumbar (Lavaflow) implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non- operative therapy. Additionally, the Blustone Synergy lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scolosis. The Blustone Synergy lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Product codes (comma separated list FDA assigned to the subject device)
MAX, ODP
Device Description
The Blustone Synergy Interbody Fusion System is composed of cervical and lumbar interbody fusion devices. The BluStone Synergy Slate Lavaflow System is a Titanium Plasma Coated cervical interbody fusion system comprised of parallel and 6° lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach. The Blustone Synergy Lumbar Interbody Lavaflow System is a Titanium Plasma Coated lumbar interbody fusion system comprised of various device configurations based on surgical approach and patient anatomy, and may be implanted via one of the following approaches: bi-laterally in pairs via a posterior (PLIF) approach; as a single device via a transverse (T-PLIF) approach; as a single device via a transforaminal (TLIF) approach; or as a single device via a lateral (LLIF) approach. All Blustone Synergy Interbody Fusion System implant components are made of polyether-ether-ketone (Zeniva ZA-500 PEEK) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. This Traditional 510(k) submission seeks to expand the sizes offered for the MAGMA LLIF cages as well as add commercially pure (CP) titanium plasma coating per ASTM F1580 to the subject new MAGMA cages as well as all previously cleared cervical and lumber interbody fusion devices. Plasma-coated implant options will be denoted as the LAVAFLOW subfamily. Finally, this submission seeks to offer all implants as sterile devices via sterilization by ethylene oxide (EO) in addition to the previously cleared non-sterile, non-coated options.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical (C2 to T1), Lumbar (L2 to 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing, including expulsion, dynamic compression per ASTM F2077, and wear debris analysis per ASTM F1877 have been performed on the subject Blustone Synergy cervical interbody devices and the results have shown them to be substantially equivalent to the predicate interbody devices.
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.
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.
K080615, K190885, K181589, K181261
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 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 7, 2021
Blustone Synergy, LLC % Christine Scifert Partner MRC Global, LLC 9085 E. Mineral Cir., Suite 110 Centennial, Colorado 80112
Re: K203520
Trade/Device Name: Blustone Synergy Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, ODP Dated: February 5, 2021 Received: February 10, 2021
Dear Christine Scifert:
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 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 -S
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Page 1 of 2
510(k) Number (if known) K203520
Device Name Blustone Synergy Slate Lavaflow System
Indications for Use (Describe)
The Blustone Synergy cervical (Slate Lavaflow) implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of carcellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative treatment. The Blustone Synergy cervical implants are also 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 PRAStaff(@fda.hhs.gov
"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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Page 2 of 2
510(k) Number (if known)
Device Name
Blustone Synergy Lumbar Interbody Lavaflow System (Basalt LAVAFLOW, Obsidian LAVAFLOW), Obsidian LAVAFLOW)
Indications for Use (Describe)
The Blustone Synergy lumbar (Lavaflow) implants are intervertebral body fusion devices indicated for use with autograff and/or allogenic bone graft comprised of cancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non- operative therapy. Additionally, the Blustone Synergy lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scolosis. The Blustone Synergy lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
Type of Use (Select one or both, as applicable)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.
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 PRAStaff(@fda.hhs.gov
"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."
4
510(k) Summary Blustone Synergy Interbody Fusion System April 6, 2021
| Company: | Blustone Synergy, LLC.
5520 Ventana Ct.
Pueblo, CO 81005
Phone: (800) 232-9108 |
|-------------------------|----------------------------------------------------------------------------------------------------------------|
| Company Contact: | Tom Gentry
Admin Manager - Blustone Synergy, LLC
admin@blustonsynergy.com
760-992-6118 |
| Official Correspondent: | Christine Scifert - MRC Global, LLC
Christine.scifert@askmrcglobal.com
901-831-8053 |
| Trade Name: | Blustone Synergy Interbody Fusion System |
| Common Name: | Intervertebral Fusion Device With Bone Graft, Cervical
Intervertebral Fusion Device With Bone Graft, Lumbar |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3080 (Intervertebral body fusion device) |
| Panel: | Orthopedic |
| Product Code: | ODP, MAX |
Device Description:
The Blustone Synergy Interbody Fusion System is composed of cervical and lumbar interbody fusion devices. The BluStone Synergy Slate Lavaflow System is a Titanium Plasma Coated cervical interbody fusion system comprised of parallel and 6° lordotic cages in two footprints with varying heights designed to accommodate patient anatomy, and may be implanted as a single device via an anterior approach. The Blustone Synergy Lumbar Interbody Lavaflow System is a Titanium Plasma Coated lumbar interbody fusion system comprised of various device configurations based on surgical approach and patient anatomy, and may be implanted via one of the following approaches: bi-laterally in pairs via a posterior (PLIF) approach; as a single device via a transverse (T-PLIF) approach; as a single device via a transforaminal (TLIF) approach; or as a single device via a lateral (LLIF) approach.
5
All Blustone Synergy Interbody Fusion System implant components are made of polyether-ether-ketone (Zeniva ZA-500 PEEK) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device.
This Traditional 510(k) submission seeks to expand the sizes offered for the MAGMA LLIF cages as well as add commercially pure (CP) titanium plasma coating per ASTM F1580 to the subject new MAGMA cages as well as all previously cleared cervical and lumber interbody fusion devices. Plasma-coated implant options will be denoted as the LAVAFLOW subfamily. Finally, this submission seeks to offer all implants as sterile devices via sterilization by ethylene oxide (EO) in addition to the previously cleared non-sterile, non-coated options.
Indications for Use:
BluStone Synergy Lumbar Interbody Lavaflow System (Basalt LAVAFLOW, Obsidian LAVAFLOW):
The Blustone Synergy lumbar (Lavaflow) implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non- operative therapy. Additionally, the Blustone Synergy lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Blustone Synergy lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.
BluStone Synergy Slate Lavaflow System:
The Blustone Synergy cervical (Slate Lavaflow) implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six weeks of non-operative treatment. The Blustone Synergy cervical implants are also to be used with supplemental fixation.
Substantial Equivalence:
The subject Blustone Synergy Interbody Fusion System is substantially equivalent to the following predicate devices:
Primary Predicate:
-
. Blustone Synergy Interbody Fusion (K171893; S.E. 09/08/2017)
Secondary Predicate: -
X-Spine Systems Inc. – Calix-C Cervical Interbody Spacer (K171075; S.E. 08/01/2017)
-
. X-Spine Systems Inc. – Calix Lumbar Spinal Implant System (K170119; S.E. 09/29/2017)
Reference devices:
- . Titan Spine – Endoskeleton® TA (K080615; S.E. 06/17/2008)
- . Elevation Spine - Elevation Spine Saber-C System (K190885; 08/07/2019)
- . Curiteva, LLC. – Curiteva Lumbar Interbody Fusion System (K181589; 12/20/2018)
6
- Curiteva, LLC. Curiteva Cervical Interbody Fusion System (K181261; 07/09/2018) .
There are insignificant differences between the subject BluStone Synergy Interbody Fusion Lavaflow System and the predicates. The Indications for Use, Materials, and Geometry for predicate devices are all inclusive of the subject device. Testing shows that the subject BluStone Synergy Interbody Fusion Lavaflow System performs equivalent to the predicate BluStone Synergy Interbody Fusion System (K171893) and reference device Endoskeleton® TA (K080615). Additionally, an engineering rationale (included in the bench performance testing section) has been provided to demonstrate that the subject MAGMA small IBDs do not introduce a new worst case to the subject system. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.
Performance Testing:
Mechanical testing, including expulsion, dynamic compression per ASTM F2077, and wear debris analysis per ASTM F1877 have been performed on the subject Blustone Synergy cervical interbody devices and the results have shown them to be substantially equivalent to the predicate interbody devices.
Conclusion:
Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.