(29 days)
Not Found
No
The document describes a mechanical spinal fixation system made of titanium alloy components and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI or ML.
Yes
The device is intended to immobilize and stabilize spinal segments as an adjunct to fusion for treating various acute and chronic instabilities or deformities, which directly addresses medical conditions and aims to restore function.
No
The device is a spinal fixation system, intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion, not for diagnosis.
No
The device description explicitly states it is comprised of "titanium alloy (6AL-4V ELI, per ASTM F136) devices in a variety of non-sterile, single use components" and is "attached to the vertebral body by means of screws and hooks," indicating it is a physical hardware device.
Based on the provided information, 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 and Intended Use: The Blackstone Spinal Fixation System is a surgical implant made of titanium alloy components. Its intended use is to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of various spinal conditions. This involves physically implanting the device into the patient's body.
The description clearly indicates a device used in vivo (within the living body) for structural support and stabilization, not a test performed in vitro (outside the living body) on biological samples.
N/A
Intended Use / Indications for Use
The Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:
- a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
- b) Who are receiving fusion using autogenous bone graft only;
- c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and
- d) Who are having the device removed after the development of a solid fusion mass.
The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
- a) Degenerative spondylolistheses with objective evidence of neurologic impairment;
- b) Fracture;
- c) Dislocation;
- d) Scoliosis;
- e) Kyphosis;
- Spinal tumor; and f)
- g) Failed previous fusion (pseudarthrosis).
The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) spondylolistheses;
- c) spinal stenosis;
- d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
- e) tumor:
- pseudoarthrosis; f)
- g) previous failed fusion; and
- h) trauma (i.e., fracture or dislocation).
The Blackstone Spinal Fixation System, when used for posterior non-pedicle screw fixation system of the non-cervical spine, is intended for the following indications:
- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) spondylolistheses;
- c) spinal stenosis;
- d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
- e) tumor;
- pseudoarthrosis; f)
- g) previous failed fusion; and
- h) trauma (i.e., fracture or dislocation).
Product codes (comma separated list FDA assigned to the subject device)
KWP, KWQ, MNH, MNI
Device Description
The Blackstone™ Spinal Fixation System is comprised of titanium alloy (6AL-4V ELI, per ASTM F136) devices in a variety of non-sterile, single use components. This system allows a surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws and hooks to the non-cervical spine.
The domino addition will function as a rod connector. There are clinical applications in which a surgeon will need to have the inter-operative ability to attach rods when extending a construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine (non-cervical), L5-S1 joint, lumbar and sacral spine (L3 and below), thoracic, lumbar and sacral spine
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Surgeon
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)
Not Found
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.
K994217, K020674, K013558, K003735, K023498, K013885, K022399, K022605
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
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.
0
FEB 2 1 2003
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Name of Firm: | Blackstone Medical, Inc.
90 Brookdale Drive
Springfield, MA 01104 |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Contact Person: Dean Ciporkin
Director of Regulatory Affairs & Quality Assurance |
| Trade Name: | Blackstone™ Spinal Fixation System
Spinal Fixation System
Domino |
| Common Name: | Rod and screw spinal instrumentation |
| Device Product Code
& Classification: | MNH – 888.3070 – Spondylolisthesis Spinal Fixation
Device System
KWQ – 888.3060 – Spinal Intervertebral Body Fixation
Orthosis
MNI – 888.3070 – Pedicle Screw Spinal System
KWP – 888.3050 – Spinal Interlaminal Fixation Orthosis |
Substantially
Equivalent Devices:
Blackstone™ Spinal Fixation System (K994217) Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screws (K020674) Blackstone™ Spinal Fixation System 4.5mm Mono-Axial Screws (K013558) Blackstone™ Spinal Fixation System 2nd Gen. Cross-Connector (K003735) Blackstone™ Spinal Fixation System Modified Multi-Axial Screws (K023498) Blackstone™ Spinal Fixation System Hooks (K013885) Blackstone™ Spinal Fixation System Spacers (K022399) Blackstone™ Spinal Fixation System Staple & Washer (K022605)
Device Description:
The Blackstone™ Spinal Fixation System is comprised of titanium alloy (6AL-4V ELI, per ASTM F136) devices in a variety of non-sterile, single use components. This system allows a surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws and hooks to the non-cervical spine.
The domino addition will function as a rod connector. There are clinical applications in which a surgeon will need to have the inter-operative ability to attach rods when extending a construct.
1
KO30241 age 2 of 3
Intended Use / Indications for Use:
The Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:
- a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
- b) Who are receiving fusion using autogenous bone graft only;
- c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and
- d) Who are having the device removed after the development of a solid fusion mass.
The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
- a) Degenerative spondylolistheses with objective evidence of neurologic impairment;
- b) Fracture;
- c) Dislocation;
- d) Scoliosis;
- e) Kyphosis;
- Spinal tumor; and f)
- g) Failed previous fusion (pseudarthrosis).
The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) spondylolistheses;
- c) spinal stenosis;
- d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
- e) tumor:
- pseudoarthrosis; f)
- g) previous failed fusion; and
- h) trauma (i.e., fracture or dislocation).
The Blackstone Spinal Fixation System, when used for posterior non-pedicle screw fixation system of the non-cervical spine, is intended for the following indications:
- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) spondylolistheses;
- c) spinal stenosis;
- d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
- e) tumor;
- pseudoarthrosis; f)
- g) previous failed fusion; and
- h) trauma (i.e., fracture or dislocation).
2
K030241
Page 3 of 3
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Blackstone™ Domino by its very nature are substantially equivalent to the Danek device which has been cleared by FDA for certain anterior and pedicle fixation use indications.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized image of a human figure with three lines extending from the head, resembling a bird in flight. The text is arranged in a circular pattern around the symbol.
FEB 2 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dean E. Ciporkin Director, Regulatory Affairs and Quality Assurance Blackstone Medical, Inc. 90 Brookdale Drive Springfield, MA 01104
Re: K030241
Trade/Device Name: Blackstone Spinal Fixation System Domino Regulation Number: 21 CFR 888.3050, 888.3060, 888.3070 Regulation Name: Spinal interlaminal fixation orthosi, Spinal intervetebral body fixation Orthosis, Spondylolisthesis spinal fixation device system, Pedicle screw spinal system Regulatory Class: II
Product Code: KWP, KWQ, MNH, MNI Dated: January 22, 2003 Received: January 23, 2003
Dear Mr. Ciporkin:
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 Mav 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.
4
Page 2 - Mr. Dean E. Ciporkin
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for Calia M. Witter, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
1030241 Page 1 of 2
510(k) Number: K 03024 (
Device Name: Blackstone™ Spinal Fixation System
Indications for Use:
The Blackstone Spinal Fixation System is intended for non-cervical use in the spine. The Blackstone Spinal Fixation System, when used for pedicle screw fixation, is intended only for patients:
- a) Having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint;
- b) Who are receiving fusion using autogenous bone graft only;
- c) Who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and
- d) Who are having the device removed after the development of a solid fusion mass.
The Blackstone Spinal Fixation System, when used as a pedicle screw system in skeletally mature patients, is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine:
- a) Degenerative spondylolistheses with objective evidence of neurologic impairment;
- b) Fracture:
- c) Dislocation:
- d) Scoliosis;
- e) Kyphosis;
- Spinal tumor; and f)
- g) Failed previous fusion (pseudarthrosis).
The Blackstone Spinal Fixation System, when used for anterolateral non-pedicle screw fixation to the non-cervical spine, is intended for the following indications:
- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) spondylolistheses;
- c) spinal stenosis;
- d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
- e) tumor;
- () pseudoarthrosis;
- g) previous failed fusion; and
- h) trauma (i.e., fracture or dislocation).
The Blackstone Spinal Fixation System, when used for posterior non-pedicle screw fixation system of the non-cervical spine, is intended for the following indications:
- a) Degenerative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) spondylolistheses;
6
(030241 ige 2 o.
c) spinal stenosis;
d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
e) tumor;
pseudoarthrosis; f)
g) previous failed fusion; and
h) trauma (i.e., fracture or dislocation).
Concurrence of CDRH, Office of device Evaluation
Prescription Use
OR
Over-The-Counter Use
Miriam C. Provost
(Division Sign-Off) (Division of General, Restorative and Neurological Devices
510(k) Number K630241