(68 days)
Not Found
No
The summary describes a mechanical spinal fixation system and does not mention any AI or ML components or functions.
Yes
The “Sequoia® Pedicle Screw System” is designed to provide “immobilization and stabilization of spinal segments” and treat various spinal conditions, indicating it is used for therapeutic purposes.
No
The text describes the Sequoia® Pedicle Screw System as a device intended for immobilization and stabilization of spinal segments, acting as an adjunct to fusion. It does not mention any diagnostic functions.
No
The device description explicitly states it consists of "open style polyaxial screws, titanium rods (varying lengths) and connectors," which are physical hardware components. The performance studies also focus on bench testing of these implants and connectors.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant system designed to provide mechanical stabilization and immobilization of the spine. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device consists of physical components (screws, rods, connectors) that are implanted into the patient. This is characteristic of a medical device used for treatment or support, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on in vitro testing.
Therefore, the Sequoia® Pedicle Screw System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
When intended for pedicle screw fixation from T1 -S1, the Sequoia® 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 the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondytolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scollosis, kyphosis, and/or lordosis), tumor and failed previous fusion.
As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.
When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity). degenerative disc disease (back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
NKB, MNH, MNI
Device Description
The Sequoia® Pedicle Screw System is designed to aid in the surgical correction of several types of spinal conditions (see indications below). This system is intended only to provide stabilization during the development of a solid fusion with a bone graft. These implants are intended to be removed after the development of a solid fusion mass.
The Sequoia® Pedicle Screw System consisting of open style polyaxial screws, titanium rods (varying lengths) and connectors is intended to provide temporary stabilization following surgery to fuse the spine. The polyaxial screw design allows the surgeon to use a top-loading technique for dropping the spinal rod down to the fixation components into a u-shaped opening.
SpeedLink II ™ Transverse Connectors are provided to increase rotational stiffness to the final construct.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T1 -S1 (thoracic, lumbar and sacral spine), L3 and S1 (posterior lumbosacral spine), T1-S1 (non-cervical spine)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Surgeons / 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)
The performance testing included components of the current Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System, which were reviewed and tested appropriately for design verification, design validation, biocompatibility and sterilization. The test results conclude the current Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System to be substantially equivalent to their predicate devices. Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System.
- . Bench testing (static compression bending, dynamic compression bending, and static torsion testing per ASTM F1717 & F1798 as applicable) for implants. polyaxial screws, titanium rods, and connectors, confirmed the product performance of the current Sequoia® Pedicle Screw System including SpeedLink II ™Transverse Connector System is suitable for its intended use.
- . Cadaver lab testing of the current Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System to evaluate human factors regarding the combination of instrument design changes and labeling design changes, as well as interaction with implants to confirm the substantial equivalence of the changes compared to the identified predicate devices.
- Biocompatibility testing ensured the current Sequoia® Pedicle Screw System . including SpeedLink !! ™Transverse Connector System materials are biocompatible after manufacturing based on the minor design changes made in comparison to the predicate devices.
- . Sterilization, Dry Time and Cleaning testing ensured the current Sequoia® Pedicle Screw System including SpeedLink ||™ Transverse Connector System steam sterilization, cleaning and dry time instructions are substantially equivalent to the predicate devices.
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.
K082032, K023644, K984578, K946348
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
510(k) SUMMARY Zimmer Spine Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System
| Date of Summary Preparation: | August 29, 2013 | |
|---|---|---|
| Submitter: | Zimmer Spine, Inc. | |
| 7375 Bush Lake Road | ||
| Minneapolis, MN 55439 | SEP 0 4 2013 | |
| Establishment Registration Number: | 2184052 | |
| Company Contact: | Jonathan Gilbert | |
| Regulatory Affairs Director | ||
| Email: jonathan.gilbert@zimmer.com | ||
| Office: 952.830.6385 | ||
| Fax: 952.837.6985 | ||
| Trade Name: | Zimmer Spine Sequoia® Pedicle Screw System | |
| including SpeedLink II™ Transverse Connector System | ||
| Device Name (Common Name): | ||
| Disease: | Orthosis, Spinal Pedicle Fixation, For Degenerative Disc | |
| Orthosis, Spondylolisthesis Spinal Fixation; Orthosis, Spinal | ||
| Pedicle Fixation | ||
| Device Classification: | Class III and Class II | |
| Product Code(s): | NKB, MNH, MNI | |
| Regulation Number: | 21 CFR §888.3070 | |
| Regulation Description: | Pedicle screw spinal system |
Predicate Devices:
For clarification purposes, this is the initial submission for this device modification and has not previously been submitted/withdrawn via a 510(k), PMA or de novo pathway. The modified Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System is claimed to be substantially equivalent to the following legally marketed predicate devices:
| Sequoia® Pedicle Screw System
Predicate Device Name | Submission ID
Number | Clearance Date |
|----------------------------------------------------------------------------------|-------------------------|-------------------|
| Sequoia® Pedicle Screw System including
Speedlink Transverse Connector System | K082032 | October 6, 2008 |
| Modification To Incompass Spinal Fixation System | K023644 | November 25, 2002 |
| Synergy D2 Spinal Implants | K984578 | March 23, 1999 |
| Titanium TSRH(R) Spinal System (Screws) | K946348 | August 7, 1995 |
1
General Device Description:
The Sequoia® Pedicle Screw System is designed to aid in the surgical correction of several types of spinal conditions (see indications below). This system is intended only to provide stabilization during the development of a solid fusion with a bone graft. These implants are intended to be removed after the development of a solid fusion mass.
The Sequoia® Pedicle Screw System consisting of open style polyaxial screws, titanium rods (varying lengths) and connectors is intended to provide temporary stabilization following surgery to fuse the spine. The polyaxial screw design allows the surgeon to use a top-loading technique for dropping the spinal rod down to the fixation components into a u-shaped opening.
SpeedLink II ™ Transverse Connectors are provided to increase rotational stiffness to the final construct.
Indications for Use:
When intended for pedicle screw fixation from T1 -S1, the Sequoia® 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 the thoracic, lumbar and sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondytolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scollosis, kyphosis, and/or lordosis), tumor and failed previous fusion.
As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.
When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity). degenerative disc disease (back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.
Summary of Technological Characteristics:
The current Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System shares the same technological characteristics as the predicate device Sequoia® Pedicle Screw System including Speed ink IIM Transverse Connector System. The characteristics include the same design, same materials, and same range of sizes, substantially equivalent performance characteristics and a subset of the indication for use.
The current and predicate Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System both consist of open style polyaxial screws, titanium rods, connectors and the instruments/accessories necessary to implant the spinal system. All implant components are made from a titanium alloy (Ti-6Al-4V) and Unalloyed Titanium (CP Ti).
2
Zimmer Spine- 510(k)-Sequoia® Pedicle Screw System-Section 5.510(k) Summary
The Sequoia® Pedicle Screw System is designed to aid in the surgical correction of several types of spinal conditions, as stated in the section above. The Sequoia® Pedicle Screw System consisting of open style polyaxial screws, titanium rods and connectors is intended to provide temporary stabilization following surgery to fuse the spine. The polyaxial screw design allows the surgeon to use a top-loading technique for dropping the spinal rod down to the fixation components into a u- shaped opening. The use of the SpeedLine II™ Transverse Connectors as a construct component during implementation of the Sequoia® Pedicle Screw System is at the discretion of the surgeon and is not required. This system is intended only to provide stabilization during the development of a solid fusion with a bone graft. These implants are intended to be removed after the development of a solid fusion mass. The current and predicate systems are provided nonsterile, are for single use only and are intended to be removed after solid fusion has occurred.
Summary of Performance Testing:
The Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System is substantially equivalent to the predicate devices in design, materials, function and intended use.
The performance testing included components of the current Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System, which were reviewed and tested appropriately for design verification, design validation, biocompatibility and sterilization. The test results conclude the current Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System to be substantially equivalent to their predicate devices. Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System.
- . Bench testing (static compression bending, dynamic compression bending, and static torsion testing per ASTM F1717 & F1798 as applicable) for implants. polyaxial screws, titanium rods, and connectors, confirmed the product performance of the current Sequoia® Pedicle Screw System including SpeedLink II ™Transverse Connector System is suitable for its intended use.
- . Cadaver lab testing of the current Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System to evaluate human factors regarding the combination of instrument design changes and labeling design changes, as well as interaction with implants to confirm the substantial equivalence of the changes compared to the identified predicate devices.
- Biocompatibility testing ensured the current Sequoia® Pedicle Screw System . including SpeedLink !! ™Transverse Connector System materials are biocompatible after manufacturing based on the minor design changes made in comparison to the predicate devices.
- . Sterilization, Dry Time and Cleaning testing ensured the current Sequoia® Pedicle Screw System including SpeedLink ||™ Transverse Connector System steam sterilization, cleaning and dry time instructions are substantially equivalent to the predicate devices.
Substantial Equivalence:
Zimmer Spine considers the current Sequoia® Pedicle Screw System including SpeedLink IITM Transverse Connector System product performance to be substantially equivalent to their cleared predicate device, Sequoia® Pedicle Screw System including SpeedLink II ™Transverse Connector System because there are no changes to the product performance specifications or device functional scientific technology.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, composed of three curved lines, positioned to the right of the text. The text, arranged in a circular fashion around the bird, reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA".
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W066-G609 Silver Spring MI) 20993-0002
September 4, 2013
Zimmer Spine, Incorporated Mr. Jonathan Gilbert Regulatory Affairs Director 7375 Bush Lake Road Minneapolis, Minnesota 55439
Re: K131980
Trade/Device Name: Zimmer Spine Sequoiad Pedicle Screw System including SpeedLink II" Transverse Connector System. Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB. MNH, MNI Dated: July 5, 2013 Received: July 8, 2013
Dear Mr. Gilbert:
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 10 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. Iisting 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 (reporting of medical
4
Page 2 - Mr. Jonathan Gilbert
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/dcfault.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mark N. Melkerson -S
Mark N. Meikerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Zimmer Spine - 510(k) - Sequoia® Pedicle Screw System
Indications for Use
510(k) Number (if known): K131980
Device Name: Zimmer Spine Sequoia® Pedicle Screw System including SpeedLink II™ Transverse Connector System
Indications for Use:
When intended for pedicie screw fixation from T1 -S1, the Sequoia® Pedicle Screw System is intended to provide immobilization 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: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), turnor and failed previous fusion.
As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after the solid fusion is established.
When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), the indications are idiopathic scoliosis, neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity, scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele, spinal fractures (acute reduction or late deformity), degenerative disc disease (back pain of discogenic origin with degenerative of the disc confirmed by history and radiographic studies), tumor, spondylolisthesis, spinal stenosis and failed previous fusion.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ronald P. Jean -S
(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131980