← Product Code [MNH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MNH) · K963045 # SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM (K963045) _Synthes (Usa) · MNH · Feb 13, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MNH/K963045 ## Device Facts - **Applicant:** Synthes (Usa) - **Product Code:** [MNH](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MNH.md) - **Decision Date:** Feb 13, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3070 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use When used as a posterior pedicle screw fixation system, the SYNTHES Universal Sacral System is intended for patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine; and who are having the device removed after the development of a solid fusion. When used as a posterior, non-pedicle screw fixation system, the SYNTHES Universal Sacral System is also intended for scoliotic, lordotic, or kyphotic deformities (such as scoliosis, Schueremann's disease); degenerative disk disease (back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), and fractures of the posterior thoracolumbar spine (levels T8-S2). ## Device Story Posterior spinal fixation system; connects screws to rods via wide array of angles; components include sacral screw assembly, sacral collar, nut, rod, rod/screw connector, locking ring. Used in clinical/surgical settings by physicians for spinal stabilization. System provides mechanical support for fusion; intended for removal after solid fusion development. Benefits include stabilization of spinal segments in deformity or fracture cases. ## Clinical Evidence No clinical data provided; substantial equivalence based on design, material, and intended use comparisons to predicate devices. ## Technological Characteristics Materials: Titanium alloy (ASTM F1295-92) and 316L stainless steel (ASTM F138-86). Mechanical fixation system consisting of screws, rods, connectors, and locking rings. Non-sterile; requires moist heat sterilization. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Universal Spinal Hook, Rod, and Pedicle/Sacral Screw Fixation System Side Opening Screw and Transverse Bar - Sofamor Danek Texas Scottish Rite Hospital (TSRH) Pedicle Spinal Screw System Variable Angle Screw - Titanium TSRH Spinal System (Screws) Variable Angle Screw ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} SYNTHES Attachment C: Summary of Safety and Effectiveness FEB 13 1997 [510(k) Summary] K963045 SYNTHES (U.S.A) 1690 Russell Road Paoli, PA 19301 (610) 647-9800 Angela Silvestri Device: SYNTHES (U.S.A.) Universal Sacral System compared to the Universal Spinal Hook, Rod, and Pedicle/Sacral Screw Fixation System Side Opening Screw and Transverse Bar, and the Sofamor Danek Texas Scottish Rite Hospital (TSRH) Pedicle Spinal Screw System Variable Angle Screw, and the Titanium TSRH Spinal System (Screws) Variable Angle Screw. When used as a posterior pedicle screw fixation system, the SYNTHES Universal Sacral System is intended for patients with severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; who are receiving fusions using autogenous bone graft only; who are having the device fixed or attached to the lumbar and sacral spine; and who are having the device removed after the development of a solid fusion. When used as a posterior, non-pedicle screw fixation system, the SYNTHES Universal Sacral System is also intended for scoliotic, lordotic, or kyphotic deformities (such as scoliosis, Schueremann's disease); degenerative disk disease (back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), and fractures of the posterior thoracolumbar spine (levels T8-S2). The overall levels of fixation for the Universal Sacral System as a whole are T8-S2. The levels of pedicle screw fixation are L3-S2. The SYNTHES (U.S.A.) Universal Sacral System allows a screw to be connected to the rod through a wide array of screw/rod angles. It consists of a sacral screw assembly with a sacral collar a nut, and a rod. The assembly consists of a sacral screw, a rod/screw connector, and a locking ring. This system is to be used with the SYNTHES (U.S.A.) Universal Spinal Hook, Rod, and Pedicle/Sacral Screw Fixation System. The SYNTHES (U.S.A.) Universal Sacral System is manufactured from titanium alloy, which conforms to ASTM Standard F1295-92, and 316L stainless steel which conforms to ASTM Standard F138-86. The SYNTHES (U.S.A.) Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System Side Opening Screw, Transverse Bar and the Texas Scottish Rite Hospital (TSRH) Variable Angle Screw are indicated for the same intended use as the SYNTHES (U.S.A.) Universal Sacral System. The SYNTHES (U.S.A.) Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System is manufactured from titanium alloy, which conforms to ASTM Standard F1295-92, and 316L stainless steel, which conforms to ASTM Standard F138-86. {1} SYNTHES The Texas Scottish Rite Hospital Variable Angle Screw is manufactured from certified Implant Grade stainless steel and a titanium alloy (Ti-6Al-4V). These systems are similar in component dimensions and sizes to the SYNTHES (U.S.A.) Universal Sacral System. The Synthes Universal Sacral System is provided non-sterile; moist heat sterilization is recommended. Based on the above, the SYNTHES (U.S.A) Universal Sacral System is substantially equivalent to the Universal Spinal Hook, Rod and Pedicle/Sacral Screw Fixation System Side Opening Screw and the Transverse Bar, and the Texas Scottish Rite Hospital (TSRH) Variable Angle Screw. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MNH/K963045](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MNH/K963045) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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