(26 days)
Not Found
No
The summary describes a mechanical spinal fixation system composed of screws and rods, with no mention of AI or ML technology in the intended use, device description, or specific sections for AI/ML details.
Yes
The device is described as a "Spinal Fixation System" intended to provide "immobilization and stabilization of spinal segments, as an adjunct to fusion" in the treatment of various spinal conditions, directly implying a therapeutic function to correct and stabilize an anatomical issue.
No
The Blackstone Spinal Fixation System is described as a system of screws and rods intended for immobilization and stabilization of spinal segments as an adjunct to fusion, treating various spinal instabilities and deformities. It is a physical implant used for treatment/stabilization, not for diagnosing conditions.
No
The device description explicitly states it consists of titanium alloy screws and rods, which are hardware components.
Based on the provided information, 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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Blackstone Spinal Fixation System is a system of screws and rods intended for surgical implantation in the spine to provide stabilization and support. It is a physical implant used in the body, not a device used to test samples from the body.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic testing.
Therefore, the Blackstone Spinal Fixation System is a surgical implant, not an In Vitro Diagnostic device.
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 (1.3 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;
f) Spinal tumor; and
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;
t) 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;
c) spinal stenosis;
d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
e) tumor;
এ pseudoarthrosis;
g) previous failed fusion; and
h) trauma (i.e., fracture or dislocation).
Product codes (comma separated list FDA assigned to the subject device)
MNH, KWQ, MNI, KWP
Device Description
The Blackstone™ Spinal Fixation System 4.5mm, 5.5mm, and 7.5mm Multi-Axial Screws are titanium alloy (6AL-4V ELI, per ASTM F136) devices, which are non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the noncervical spine.
The Blackstone Spinal Fixation System consists of an assortment of screws and rods which have received 510(k) clearance (#K994217, and #K020674).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine, L5-S1 joint, lumbar and sacral spine, thoracic, lumbar and sacral 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)
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, K980477, K982320
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
KO23498
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Name of Firm: | Blackstone Medical, Inc.
90 Brookdale Drive
Springfield, MA 01104 |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Dean E. Ciporkin
Director, Regulatory Affairs and Quality Assurance |
| Trade Name: | Blackstone™ Spinal Fixation System
Spinal Fixation System
Multi-Axial Screws |
| 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 |
| Substantially
Equivalent Devices: | Blackstone™ Spinal Fixation System (K994217)
Blackstone™ Spinal Fixation System 4.5mm Multi-Axial Screws
(K020674) |
Device Description:
The Blackstone™ Spinal Fixation System 4.5mm, 5.5mm, and 7.5mm Multi-Axial Screws are titanium alloy (6AL-4V ELI, per ASTM F136) devices, which are non-sterile, single use components that allow the surgeon to build a spinal implant construct. The system is attached to the vertebral body by means of screws to the noncervical spine.
The Blackstone Spinal Fixation System consists of an assortment of screws and rods which have received 510(k) clearance (#K994217, and #K020674).
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;
Page 1 of 3
1
KOZ3498
- 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 (1.3 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;
- f) Spinal tumor; and
- 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;
- spinal stenosis; c)
- d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
- e) tumor;
- pseudoarthrosis; t)
- 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;
- এ pseudoarthrosis;
- g) previous failed fusion; and
- h) trauma (i.e., fracture or dislocation).
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Blackstone™ 4.5mm, 5.5mm, 6.5mm, and 7.5mm Multi-Axial Screws by their very nature are substantially equivalent to the DePuy Motech Moss Miami Spinal
Page 2 of 3
2
System (K980477, K982320) which has been cleared by FDA for certain anterior and pedicle fixation use indications.
Page 3 of 3
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
od and Drug Administration 200 Corporate Boulevard Rockville MD 20850
Dean E. Ciporkin Director, Regulatory Affairs and Quality Assurance Blackstone Medical, Inc. 90 Brookdale Drive Springfield. Massachusetts 01104
Re: K023498
Trade/Device Name: Blackstone Spinal Fixation System Regulation Number: 21 CFR 888.3050, 888.3060, 888.3070
Regulation Name: Spinal interlaminal fixation orthosis; Spinal intervetebral body fixation orthosis; Spondylolisthesis spinal fixation device system; Pedicle screw spinal system
Regulatory Class: Class II Product Code: KWP, KWQ, MNH, MNI Dated: October 14, 2002 Received: October 18, 2002
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 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. 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
4
Page 2 -- Mr. Dean E. Ciporkin
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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
Sincerely yours,
Mark N Milliman
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
510(k) Number: K023498
Device Name: Blackstone™ Spinal Fixation S
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 (1.3 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 instabilitics 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 C
- 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);
- spondylolistheses; b)
- spinal stenosis: c)
- spinal deformities (i.e., scoliosis, kyphosis, lordosis); d)
- tumor; e)
- pseudoarthrosis: ()
- previous failed fusion; and g)
- 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) Degencrative disc disease (as defined as back pain of discogenic origin with degenerative disc confirmed by history and radiographic studies);
- b) spondylolistheses;
Mark A. Millican
Page 1 of 2
Neurological
510(k) Numbe
6
- spinal stenosis; c)
- spinal deformities (i.e., scoliosis, kyphosis, lordosis); d)
್ಗಳು
e) tumor;
- pseudoarthrosis; f)
- previous failed fusion; and g)
- h) trauma (i.e., fracture or dislocation).
Concurrence of CDRH, Office of device Evaluation
OR
Mark N Melkerin
(Division Sign-Off)
Division of Gener iestorative and Neurological L ් පිළිප
510(k) Number K023498
Prescription Use Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________