(60 days)
Not Found
No
The summary describes a mechanical spinal screw system and its intended use, materials, and performance testing. There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies are standard mechanical tests for spinal implants.
Yes.
The device is intended to provide additional support during fusion using autograft or allograft in the treatment of various acute and chronic instabilities or deformities in the non-cervical spine, which are therapeutic actions.
No
This device is a spinal screw system designed to provide additional support during spinal fusion. Its intended use is for treatment, not diagnosis, of various spinal conditions.
No
The device description explicitly lists physical components like screws, rods, hooks, and surgical instruments, and the performance studies are focused on mechanical testing of these physical implants. There is no mention of software as a component or function of the device.
No, 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 RIPLEY SPINAL SCREW SYSTEM BY SAGICO is a system of implants (screws, rods, hooks, etc.) designed to be surgically implanted into the non-cervical spine. Its purpose is to provide structural support during spinal fusion procedures to treat various spinal conditions.
- Lack of Specimen Analysis: The device does not interact with or analyze any specimens taken from the body. It is a physical implant used to stabilize the spine.
Therefore, based on the provided information, the RIPLEY SPINAL SCREW SYSTEM BY SAGICO is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The RIPLEY SPINAL SCREW SYSTEM BY SAGICO is intended for use in the non-cervical spine. When used for anterior/anteral and posterior, non-cervical pedicle and non-pedicle fixation system, the RIPLEY SPINAL SCREW SYSTEM BY SAGICO is intended to provide additional support during fusion using autograft or allograft in Skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
- Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- Spondylolisthesis;
- Trauma (i.e. fracture or dislocation);
- Spinal stenosis;
- Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
- Tumor;
- Pseudoarthrosis; and
- Failed previous fusion
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the RIPLEY SPINAL SCREW SYSTEM BY SAGICO implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis.
The RIPLEY SPINAL SCREW SYSTEM BY SAGICO for pediative use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Product codes
NKB, KWP, KWQ
Device Description
The RIPLEY SPINAL SCREW SYSTEM BY SAGICO constructs of monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking cap set screws, rods, hooks, monoaxial and multiaxial transverse connectors and associated surgical instruments. The RIPLEY SPINAL SCREW SYSTEM BY SAGICO implants are available in a variety of sizes to accommodate individual patient anatomy and pathology conditions. RIPLEY SPINAL SCREW SYSTEM BY SAGICO is designed to adapt 5.5mm diameter rods; the implants are manufactured from Ti6A14V alloy and offered in a sterile package option.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
non-cervical spine
Indicated Patient Age Range
Skeletally mature patients, pediatric patients (specifically for adolescent idiopathic scoliosis)
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
Non-clinical performance data testing conducted to support substantial equivalence for the RIPLEY SPINAL SCREW SYSTEM BY SAGICO device included:
ASTM F1717
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- Static Compression Bending Test
- Dynamic Compression Bending Test
ASTM F1798
Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- Axial Gripping Test
- Axial Torsion Gripping Test
- Flexion Extension Static Test
Key Metrics
Not Found
Predicate Device(s)
K180220, K113666, K071373, K091445, K994121, K111492
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
October 23, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of a human figure, while the right side features the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Sagico VA USA, LLC James Gibson, PhD President 2189 West Busch Blvd. Tampa, Florida 33612
Re: K232561
Trade/Device Name: Ripley Spinal Screw System by SAGICO Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP, KWQ Dated: August 18, 2023 Received: August 24, 2023
Dear Dr. Gibson:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Katherine D. Kavlock -S
for
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
2
Indications for Use
510(k) Number (if known) K232561
Device Name
Ripley Spinal Screw System by SAGICO
Indications for Use (Describe)
The RIPLEY SPINAL SCREW SYSTEM BY SAGICO is intended for use in the non-cervical spine. When used for anterior/anteral and posterior, non-cervical pedicle and non-pedicle fixation system, the RIPLEY SPINAL SCREW SYSTEM BY SAGICO is intended to provide additional support during fusion using autograft or allograft in Skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
- Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
- Spondylolisthesis;
- Trauma (i.e. fracture or dislocation);
- Spinal stenosis;
- Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
- Tumor;
- Pseudoarthrosis; and
- Failed previous fusion
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the RIPLEY SPINAL SCREW SYSTEM BY SAGICO implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis.
The RIPLEY SPINAL SCREW SYSTEM BY SAGICO for pediative use is intended to be used with autograft and/or allograft. 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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3
Image /page/3/Picture/1 description: The image is a logo for SAGICO UNITED STATES OF AMERICA GOVERNMENT AFFAIRS. The logo is a hexagon shape with the top half of the hexagon containing a blue background with white stars. The bottom half of the hexagon contains red and white stripes. The text "SAGICO UNITED STATES OF AMERICA" is in the center of the hexagon. The text "GOVERNMENT AFFAIRS" is at the bottom of the hexagon.
SAGICO VA USA SPINAL SYSTEM TRADITIONAL 510(K) PREMARKET NOTIFICATION
510(k) Summary
| Device Trade Name(s): | Ripley Spinal Screw System by SAGICO |
|---|---|
| Classification Panel: | Orthopedic |
| Common Name: | Pedicle Screw Spinal System |
| Class and Reference: | Class II |
| Product Code(s): | NKB, KWQ, KWP |
| Classification Name(s): | Thoracolumbosacral Pedicle Screw System (NKB) |
| Class II per 21 CFR §888.3070 | |
| Appliance, Fixation, Spinal Intervertebral Body (KWQ) | |
| Class II per 21 CFR §888.3060 | |
| Appliance, Fixation, Spinal Interlaminal (KWP) | |
| Class II per 21 CFR §888.3050 | |
| Applicant/Official Contact Person: | James J. Gibson, Jr., PhD, CPA, |
| SAGICO VA USA, LLC, Project Manager | |
| Email: JG@SAGICOUSA.com | |
| Tel. (813) 815-0613 | |
| Submitter /Manufacturer: | SAGICO VA USA, LLC |
| 2189 West Busch Blvd | |
| Tampa, Florida 33612 | |
| Tel. (813) 815-0613 | |
| Preparation Date: | August 18, 2023 |
Predicate Devices :
The subject device is substantially equivalent to the primary predicate device: SAGICO OSI SPINAL SYSTEM by Osimplant (K180220), the XIA® 3 Spinal System - Stryker Spine (K113666) and additional predicate devices, USS Small Stature System - Synthes Spine (K071373), CD HORIZON Spinal System - Sofamor Danek USA (K091445), TSRH Spinal System - Sofamor Danek USA (K994121), XIA 3 Spinal System - Stryker Spine (K111492)
Purpose:
The purpose of this submission is to request clearance for the system known as the "RIPLEY SPINAL SCREW SYSTEM BY SAGICO".
4
Image /page/4/Picture/1 description: The image is a logo for SAGICO UNITED STATES OF AMERICA GOVERNMENT AFFAIRS. The logo is a hexagon shape with the words "SAGICO UNITED STATES OF AMERICA" in large letters across the top. Below that, the words "GOVERNMENT AFFAIRS" are written along the bottom. The hexagon is filled with a pattern of red and white stripes and blue stars, reminiscent of the American flag.
SAGICO VA USA SPINAL SYSTEM TRADITIONAL 510(K) PREMARKET NOTIFICATION
Device Description:
The RIPLEY SPINAL SCREW SYSTEM BY SAGICO constructs of monoaxial screws, uniplanar screws, polyaxial screws, reduction screws, locking cap set screws, rods, hooks, monoaxial and multiaxial transverse connectors and associated surgical instruments. The RIPLEY SPINAL SCREW SYSTEM BY SAGICO implants are available in a variety of sizes to accommodate individual patient anatomy and pathology conditions. RIPLEY SPINAL SCREW SYSTEM BY SAGICO is designed to adapt 5.5mm diameter rods; the implants are manufactured from Ti6A14V alloy and offered in a sterile package option.
Indications for use:
The RIPLEY SPINAL SCREW SYSTEM BY SAGICO is intended for use in the non-cervical spine. When used for anterior/anterolateral and posterior, non-cervical pedicle fixation system, the RIPLEY SPINAL SCREW SYSTEM BY SAGICO is intended to provide additional support during fusion using autograft or allograft in Skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:
-
Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the . disc
confirmed by history and radiographic studies); -
Spondylolisthesis; ●
-
Trauma (i.e. fracture or dislocation); ●
-
Spinal stenosis:
-
Curvatures (i.e. scoliosis, kyphosis, and/or lordosis);
-
Tumor:
-
Pseudoarthrosis; and ●
-
Failed previous fusion
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the RIPLEY SPINAL SCREW SYSTEM BY SAGICO implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis.
The RIPLEY SPINAL SCREW SYSTEM BY SAGICO for pediatric use is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
Technological Characteristics:
Testing performed on RIPLEY SPINAL SCREW SYSTEM BY SAGICO included in this submission demonstrates that the RIPLEY SPINAL SCREW SYSTEM BY SAGICO is substantially equivalent to predicate devices cleared by FDA for commercial distribution in the United States market. The RIPLEY SPINAL SCREW SYSTEM BY SAGICO substantial equivalence determination to the predicate systems is based on comparable data drawn from design, labeling, and indications for use, function and implant materials.
5
Image /page/5/Picture/1 description: The image is a logo for SAGICO UNITED STATES OF AMERICA GOVERNMENT AFFAIRS. The logo is a hexagon shape with the top half of the hexagon being blue and white stars and the bottom half being red and white stripes. The text "SAGICO" is in large, bold letters in the center of the hexagon, with the words "UNITED STATES OF AMERICA" below it in smaller letters. The words "GOVERNMENT AFFAIRS" are written along the bottom of the hexagon.
SAGICO VA USA SPINAL SYSTEM TRADITIONAL 510(K) PREMARKET NOTIFICATION
Performance data:
Non-clinical performance data testing conducted to support substantial equivalence for the RIPLEY SPINAL SCREW SYSTEM BY SAGICO device included:
ASTM F1717
Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
- Static Compression Bending Test
- Dynamic Compression Bending Test ●
ASTM F1798
Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
- Axial Gripping Test ●
- Axial Torsion Gripping Test ●
- Flexion Extension Static Test ●
Basis of Substantial Equivalence:
The RIPLEY SPINAL SCREW SYSTEM BY SAGICO has been found to be substantially equivalent to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided within this premarket notification supports substantial equivalence of the subject and predicate devices.
Conclusion:
The RIPLEY SPINAL SCREW SYSTEM BY SAGICO has been shown to be substantially equivalent to legally marketed predicate devices with respect to its indications for use, design, function, and materials.