(84 days)
No
The summary describes a mechanical spinal fixation system and does not mention any software, algorithms, or AI/ML capabilities.
Yes.
The device is intended to provide immobilization and stabilization of spinal segments for various acute and chronic instabilities or deformities, which is a therapeutic function aimed at treating medical conditions.
No
The device is a pedicle screw system intended for immobilization and stabilization of spinal segments, acting as an adjunct to fusion. It is a treatment device, not a diagnostic one.
No
The device description explicitly states it consists of physical components: pedicle screws, rods, and cross links.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Black Diamond Pedicle Screw System is a "posterior spinal fixation system" consisting of "pedicle screws, rods, and cross links." Its intended use is to "provide immobilization and stabilization of spinal segments... as an adjunct to fusion."
- Lack of Mention of Samples or Testing: There is no mention of the device being used to analyze samples from the body or perform any kind of diagnostic test.
The Black Diamond Pedicle Screw System is a surgical implant used to stabilize the spine, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Black Diamond Pedicle Screw System, with or without MIS instrumentation, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Black Diamond Pedicle Screw System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Black Diamond Pedicle Screw System is intent patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatic pedicle screw fixation is limited to a posterior approach.
Product codes (comma separated list FDA assigned to the subject device)
NKB
Device Description
The Black Diamond Pedicle Screw System is a top loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, and cross links. All the components are available in a variety of sizes to match more closely the patient's anatomy
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic, lumbar, and sacral spine
Indicated Patient Age Range
skeletally mature patients, pediatric 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)
Non-clinical Test Summary:
The following analyses were conducted:
● Static and dynamic compression per ASTM F1717
● Static torsion per ASTM F1717
The results of these evaluations show that the Black Diamond Pedicle Screw System is equivalent to predicate devices.
Clinical Test Summary: No clinical studies were performed
Conclusions: Non-clinical and Clinical:
Osseus Fusion Systems considers the Black Diamond Pedicle Screw System to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in principles of operation, technology, materials, and indications for use.
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.
INERTIA Pedicle Screw System, NEXXT Spine (K090984/ K101278/ K132412/
K153453), Black Diamond Pedicle Screw System, Osseus Fusion Systems (K131810), Vitality® Spinal Fixation System, Zimmer Spine, Inc. (K150896 / K1719007), Xia® 3 Spinal System, Stryker Spine (K091291 / K113666 / K142381), Savannah-T Dual Fix, Amendia (K132925)
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.
Synergy VLS - open, Cross Medical Products (K940631 / K950099), Moss Miami SS, DePuy Spine (K950697), Rogozinski, Smith & Nephew Richards (K954696)
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.
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October 29, 2019
Image /page/0/Picture/1 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Osseus Fusion Systems % J.D.Webb Official Correspondent The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, Utah 84401
Re: K192121
Trade/Device Name: Black Diamond Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: July 31, 2019 Received: August 6, 2019
Dear Mr. Webb:
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.
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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 (OS) 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 medical devices and radiation-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.
for
Ronald Jean, Ph.D. Acting 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
510(k) Number (if known) K192121
Device Name
Black Diamond Pedicle Screw System
Indications for Use (Describe)
The Black Diamond Pedicle Screw System, with or without MIS instrumentation, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion.
When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Black Diamond Pedicle Screw System implants are indicated as an adjunct to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Black Diamond Pedicle Screw System is intent patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. This system is intended to be used with autograft and/or allograft. Pediatic pedicle screw fixation is limited to a posterior approach.
| 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) |
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K192121 510(k) Summary: Black Diamond Pedicle Screw System
| Date Prepared | July 31, 2019 |
|---|---|
| Submitted By | Osseus Fusion Systems, LLC |
| 2703 W. Mockingbird Ln., Ste. #102 | |
| Dallas, TX 75204 | |
| Primary Contact | J.D. Webb |
| 4313 W. 3800 S. | |
| West Haven, UT 84401 | |
| 512-590-5810 Tele | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | Black Diamond Pedicle Screw System |
| Common Name | pedicle screw system |
| Classification Name | Thoracolumbosacral Pedicle Screw System |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | |
| Class | ll |
| Product Code | NKB |
| CFR Section | 21 CFR section 888.3070 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | INERTIA Pedicle Screw System, NEXXT Spine (K090984/ K101278/ K132412/ |
| K153453) | |
| Secondary Predicate | |
| Devices | Black Diamond Pedicle Screw System, Osseus Fusion Systems (K131810) |
| Vitality® Spinal Fixation System, Zimmer Spine, Inc. (K150896 / K1719007) | |
| Xia® 3 Spinal System, Stryker Spine (K091291 / K113666 / K142381) | |
| Savannah-T Dual Fix, Amendia (K132925) | |
| Reference Predicate | |
| Devices | Synergy VLS - open, Cross Medical Products (K940631 / K950099) |
| Moss Miami SS, DePuy Spine (K950697) | |
| Rogozinski, Smith & Nephew Richards (K954696) | |
| Device Description | The Black Diamond Pedicle Screw System is a top loading, multiple component, |
| posterior spinal fixation system which consists of pedicle screws, rods, and cross links. | |
| All the components are available in a variety of sizes to match more closely the patient's | |
| anatomy | |
| Materials | Ti-6Al-4V per ASTM F136 |
| CoCr per ASTM F1537 | |
| Intended Use | Black Diamond Pedicle Screw System is intended to provide immobilization and |
| stabilization of spinal segments until fusion is accomplished | |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The Black Diamond Pedicle Screw System is equivalent to the predicate devices in |
| terms of intended use, design, materials used, mechanical safety and performances. | |
| Indications for Use | The Black Diamond Pedicle Screw System, with or without MIS instrumentation, is |
| 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 thoracic, lumbar, and sacral spine: degenerative disc disease | |
| (defined as back pain of discogenic origin with degeneration of the disc confirmed by | |
| history and radiographic studies), degenerative spondylolisthesis with objective evidence | |
| of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, | |
| kyphosis, and/or lordosis), spinal tumor, pseudarthrosis and failed previous fusion. | |
| When used for posterior, non-cervical, pedicle screw fixation in pediatric patients, the Black | |
| Diamond Pedicle Screw System implants are indicated as an adjunct to fusion to treat | |
| progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic | |
| scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Black | |
| Diamond Pedicle Screw System is intended to treat pediatric patients diagnosed with | |
| spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, | |
| and/or failed previous fusion. This system is intended to be used with autograft and/or | |
| allograft. Pediatric pedicle screw fixation is limited to a posterior approach. | |
| Summary of the | |
| technological | |
| characteristics | |
| compared to | |
| predicate | Intended Use |
| The Black Diamond Pedicle Screw System and all the predicates have similar intended | |
| uses. | |
| Materials | |
| The Black Diamond Pedicle Screw System is fabricated from the same material as the | |
| predicate devices. | |
| Design Features/Functions | |
| The Black Diamond Pedicle Screw System and cited predicate devices share similar basic | |
| design features and functions. | |
| Dimensions | |
| The Black Diamond Pedicle Screw System is dimensionally similar to cited predicate | |
| devices. | |
| Sterilization | |
| The Black Diamond Pedicle Screw System is supplied non-sterile and cited predicate | |
| devices are non-sterile. | |
| Performance Specification | |
| Mechanical testing confirmed the Black Diamond Pedicle Screw System showed as good | |
| or better performance to the cited predicate devices under the same test conditions. | |
| Non-clinical Test | |
| Summary | The following analyses were conducted: |
| ● Static and dynamic compression per ASTM F1717 | |
| ● Static torsion per ASTM F1717 |
The results of these evaluations show that the Black Diamond Pedicle Screw System is
equivalent to predicate devices. |
| Clinical Test
Summary | No clinical studies were performed |
| Conclusions: Non-
clinical and Clinical | Osseus Fusion Systems considers the Black Diamond Pedicle Screw System to be
equivalent to the predicate devices listed above. This conclusion is based upon the
devices' similarities in principles of operation, technology, materials, and indications for
use. |
In accordance with 21 CFR 807.92 of the Federal Code of Regulations
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