(122 days)
Not Found
No
The summary describes a mechanical spinal fixation system made of titanium alloy components. There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
Yes.
The device is intended to immobilize and stabilize spinal segments to treat various instabilities and deformities, such as spondylolisthesis, fractures, and scoliosis, which are therapeutic interventions.
No
The Blackstone Spinal Fixation System is described as a spinal implant construct intended for fixation and stabilization, not for identifying a condition.
No
The device description explicitly states it is comprised of titanium alloy devices and components, indicating it is a hardware-based medical device.
Based on the provided text, the Blackstone Spinal Fixation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- The description of the Blackstone Spinal Fixation System clearly states it is a system of implants made of titanium alloy components intended to be surgically attached to the vertebral body to provide immobilization and stabilization of spinal segments.
- The intended use and device description focus on surgical implantation and mechanical support within the body, not on analyzing biological samples.
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
- Who are having the device removed after the development of a solid fusion mass. d)
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;
- f) 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 orioin with degenerative disc confirmed by history and radiographic studies);
- b) spondylolistheses;
- c) spinal stenosis;
- d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
- e) tumor;
- f) 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, MNI, KWP, KWQ
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 lateral offset addition will function as an offset rod connector. There are clinical applications in which a surgeon will need to have the inter-operative ability to attach rods in an offset manner when building a construct.
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 (L3 and below), 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, 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
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.
0
Premarket Notification Special 510(k) Blackstone Medical, Inc. Blackstone™ Spinal Fixation System Lateral Offset (System Modification) Confidential
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 of Regulatory Affairs and QA |
| Trade Name: | Blackstone™ Spinal Fixation System
Spinal Fixation System
Lateral Offset |
| 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 lateral offset addition will function as an offset rod connector. There are clinical applications in which a surgeon will need to have the inter-operative ability to attach rods in an offset manner when building a construct.
Siimmarv
1
Revision ೧
นุง ใ
1
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
- Who are having the device removed after the development of a solid fusion mass. d)
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;
- f) 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 orioin with degenerative disc confirmed by history and radiographic studies);
- b) spondylolistheses;
- c) spinal stenosis;
- d) spinal deformities (i.e., scoliosis, kyphosis, lordosis);
- e) tumor;
- f) pseudoarthrosis;
- g) previous failed fusion; and
- h) trauma (i.e., fracture or dislocation).
Summary
2
્લાળ Revision 0
2
Premarket Notification Special 510(k) Blackstone Medical, Inc. Blackstone™ Spinal Fixation System Lateral Offset (System Modification) Confidential
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Blackstone™ Lateral Offset by its very nature is substantially equivalent to the Synthes, Interpore Cross and Surgical Dynamics devices, which have been cleared by FDA for certain indications.
Summary
3
પ્રી
Revision 0
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.
Public Health Service
JUN 2 6 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, Massachusetts 01104
Re: K030581 Device name: Blackstone™ Spinal Fixation System - Lateral Offset Regulatory Name(s): 888.3060 Spinal intervertebral body fixation orthosis 888.3070 Pedicle screw spinal system 888.3050 Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: MNH, MNI, KWP, KWQ Dated: May 28, 2003
Received: May 30, 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 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 aftthe 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
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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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
b-Mark-A-Milkerson
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
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Indications for Use Statement
510(k) Number (if known): _ 10 205
Device Name: ORIA Spinal Clip System
Indications for Use:
When used as a nonpedicle, noncervical posterior system, the ORIA Spinal Clip System is indicated for: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confined by socies is also in the studies); (2) spondylolisthesis; (3) fracture; (4) spinal stenosis; (5) deformities (i., , scoliosis, kyphosis, lordosis), (5) tumor, (6) pseudarthrosis, (7) turnor resection, and/or (8) failed previous fusion.
ORIA Spinal Clip System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) at L5-S1 joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of solid fusion mass.
When used as a pedicle screw system in the non-cervical spine of skeletally mature patients, the ORIA Spinal Clip System is indicated for immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacal spine: (1) degenerative spondylolisthesis with objective evidence of neurological impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and (7) failed previous fusion (pseudatthrosis).
. Mark N. Milkerson
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use_
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Confidential: DORIA SPINAL CLIP SYSTEM Sacral Connectors Modification
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