(154 days)
No
The 510(k) summary describes a mechanical pedicle screw system and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are non-clinical and focus on equivalence to predicate devices.
Yes
The device is described as an "adjunct to fusion" and is intended to provide "immobilization and stabilization of spinal segments" as a treatment for various acute and chronic instabilities or deformities, which directly addresses a medical condition.
No
Explanation: The device description clearly states that the Calvary Spine Pedicle Screw System "includes screws and connecting components." The "Intended Use / Indications for Use" section describes its purpose as providing "immobilization and stabilization of spinal segments as an adjunct to fusion," treating various spinal conditions by mechanically supporting the spine. This indicates a therapeutic, not a diagnostic, function.
No
The device description explicitly states that the system includes "screws and connecting components," which are physical hardware implants.
Based on the provided information, the Calvary Spine Pedicle Screw System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. This system is a surgical implant used to stabilize the spine.
- The intended use describes a surgical procedure and the conditions it treats. It does not involve testing or analyzing biological samples.
- The device description details physical components for surgical implantation. It does not mention reagents, test kits, or analytical equipment.
Therefore, the Calvary Spine Pedicle Screw System falls under the category of a surgical implant or orthopedic device, not an IVD.
N/A
# Intended Use / Indications for Use
The Calvary Pedicle Screw System 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. Iumbar, and sacral spine (T1 to S1/ilium); 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 (T1 to S1/ilum), pedicte screw fixation in pediatric patients, the Calvary Spine Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Calvary Spine 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. Pediatric pedicle screw fixation is limited to a posterior approach.
# Product codes (comma separated list FDA assigned to the subject device)
NKB
# Device Description
Calvary Spine Pedicle Screw System includes screws and connecting components in a wide variety of sizes and shapes, which can be locked in various configurations, each assembly being tailor-made. Calvary pedicular screws must be used with Ø 5.5mm straight and curved rods.
# Mentions image processing
Not Found
# Mentions AI, DNN, or ML
Not Found
# Input Imaging Modality
Not Found
# Anatomical Site
thoracic, lumbar, and sacral spine (T1 to S1/ilium)
# 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 results of these evaluations indicate that the Calvary Spine Pedicle Screw System is equivalent to predicate devices.
Clinical Test Summary: No clinical studies were performed
# 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.
[K101682](https://510k.innolitics.com/search/K101682)
# 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.
[K111136](https://510k.innolitics.com/search/K111136), [K131802](https://510k.innolitics.com/search/K131802), [K200245](https://510k.innolitics.com/search/K200245), [K940631](https://510k.innolitics.com/search/K940631), [K950099](https://510k.innolitics.com/search/K950099), [K920116](https://510k.innolitics.com/search/K920116), [K000536](https://510k.innolitics.com/search/K000536), [K955348](https://510k.innolitics.com/search/K955348)
# 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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November 12, 2020
Image /page/0/Picture/1 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Calvary Spine, LLC % J.D. Webb Official Correspondent The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven. Utah 84401
Re: K201568
Trade/Device Name: Calvary Spine Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: October 12, 2020 Received: October 15, 2020
Dear J.D. 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.
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
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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,
Colin O'Neill. M.B.E. 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
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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K201568
Device Name
Calvary Spine Pedicle Screw System
Indications for Use (Describe)
The Calvary Pedicle Screw System 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. Iumbar, and sacral spine (T1 to S1/ilium); 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 (T1 to S1/ilum), pedicte screw fixation in pediatric patients, the Calvary Spine Pedicle Screw System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the Calvary Spine 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. Pediatric 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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510(k) Summary: Calvary Spine Pedicle Screw System
| Date Prepared | September 14, 2020 |
|---|---|
| Submitted By | Calvary Spine, LLC |
| 308 North Wind Road | |
| Towson, MD 21204 | |
| Primary Contact | J.D. Webb |
| 4313 W. 3800 S | |
| West Haven, UT 84401 | |
| 512-590-5810 Tele | |
| e-mail: jdwebb@orthomedix.net | |
| Trade Name | Calvary Spine Pedicle Screw System |
| Common Name | Thoracolumbosacral Pedicle Screw System |
| Classification Name | Thoracolumbosacral Pedicle Screw System |
| Class | II |
| Product Code | NKB |
| CFR Section | 21 CFR section 888.3070 |
| Device Panel | Orthopedic |
| Primary Predicate | |
| Device | S100 Pedicle Screw System, Renovis Surgical Technologies (K101682) |
| Reference Predicate | |
| Devices | EXPEDIUM®/Viper Spine System, Medos International SARL (K111136 / K131802 / |
| K200245) | |
| Synergy VLS - open, Cross Medical (K940631 / K950099) | |
| PWB (now Synergy), Cross Medical (K920116) | |
| Moss Miami SS, DePuy Spine (K000536) | |
| Moss Miami Ti, DePuy Spine (K955348) | |
| Device Description | Calvary Spine Pedicle Screw System includes screws and connecting components in a |
| wide variety of sizes and shapes, which can be locked in various configurations, each | |
| assembly being tailor-made. Calvary pedicular screws must be used with Ø 5.5mm straight | |
| and curved rods. | |
| Materials | Ti-6Al-4V ELI per ASTM F136 |
| CP Titanium per ASTM F67 | |
| CoCrMo per ASTM F1582 | |
| Intended Use | The Calvary Spine Pedicle Screw System is a spinal fixation system intended to help |
| provide immobilization and stabilization of spinal segments as an adjunct to fusion of the | |
| thoracic, lumbar, and/or sacral spine. | |
| Substantial | |
| Equivalence Claimed | |
| to Predicate Devices | The Calvary Spine Pedicle Screw System is substantially equivalent to the predicate |
| devices in terms of intended use, design, materials used, mechanical safety and | |
| performances. | |
| Indications for Use | The Calvary Spine Pedicle Screw System 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 (T1 to S1/ilium): 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 stenosis, spinal tumor, pseudarthrosis and failed previous fusion. |
When used for posterior, non-cervical (T1 to S1/ilium), pedicle screw fixation in pediatric
patients, the Calvary Spine 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
Calvary Spine 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 Calvary Spine Pedicle Screw System and the predicate device are spinal fixation
systems intended to help provide immobilization and stabilization of spinal segments as
an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. |
| | All of the devices comply with the indications for use specified in 21 CFR section 888.3070
for thoracolumbosacral pedicle screw systems. |
| | Material
The Calvary Spine Pedicle Screw System uses the same material as the predicate. |
| | Design
The Calvary Spine Pedicle Screw System and the predicate are equivalent in terms
of shape, sizes, material, and manufacturing process. |
| | Strength
The Calvary Spine Pedicle Screw System has greater or equivalent strength values
compared to other devices cleared for use in the thoracolumbosacral spine. |
| | Non-clinical Test
Summary |
| | The results of these evaluations indicate that the Calvary Spine Pedicle Screw System is
equivalent to predicate devices. |
| Clinical Test Summary | No clinical studies were performed |
| Conclusions: Non-
clinical and Clinical | Calvary Spine, LLC considers the Calvary Spine 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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