← Product Code [KWP](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP) · K963639 # ACROMED PEDICLE SCREW (K963639) _Acromed Corp. · KWP · Nov 14, 1996 · Orthopedic · SN_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K963639 ## Device Facts - **Applicant:** Acromed Corp. - **Product Code:** [KWP](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP.md) - **Decision Date:** Nov 14, 1996 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3050 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Indications for Use The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft and intended to be removed after solid fusion is attained. The ISOLA Spinal System, when not used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft and intended to be removed after solid fusion is attained. ## Device Story AcroMed Pedicle Screw (4.75 mm) is a spinal fixation component for the ISOLA Spine System. Device features two-section design: long cancellous section with integral fixed lower nut; machine-threaded section with hexagonal drive head. Integral nut provides bolt connection strength and reduces stress concentration. Supplied with adjustable tapered nut and optional lock nut for rod-to-screw connection. Used by surgeons in spinal fusion procedures to stabilize L5-S1 segments in spondylolisthesis patients. Removed after solid fusion achieved. ## Clinical Evidence Bench testing only. Static and fatigue testing performed to demonstrate consistency with previously cleared components. ## Technological Characteristics Material: Implant grade stainless steel (ASTM F1314). Dimensions: 4.75 mm diameter; cancellous thread lengths 25-50 mm (5 mm increments). Design: Two-section screw with integral fixed lower nut, machine-threaded section, and hexagonal drive head. Mechanical fixation. ## Regulatory Identification A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome. ## Predicate Devices - AcroMed pedicle screws ([K951116](/device/K951116.md)) ## Reference Devices - ISOLA Spine System ([K944737](/device/K944737.md)) ## 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} K963639 1 of 2 NOV 14 1996 # ISOLA SYSTEM ## AcroMed Pedicle Screw (4.75 mm) ### 510(k) SUMMARY **COMPANY:** AcroMed Corporation 3303 Carnegie Avenue Cleveland, OH 44115 **TRADENAME:** AcroMed Pedicle Screw **CLASSIFICATION:** Spondylolisthesis Spinal Fixation Device Unclassified, preamendment device system **DESCRIPTION:** The AcroMed Pedicle Screw is composed of two sections: a long cancellous section with an integral fixed lower nut, and a machine threaded section topped with an hexagonal drive head. The integral nut serves two purposes: it creates a stronger bolt connection between the screw and rod and it eliminates the “claw hammer” effect associated with other screw designs. The AcroMed Pedicle Screw is supplied with an adjustable tapered nut and an optional lock nut, which enables a pedicle screw and a slotted connector to be adjoined utilizing a locking nut system. The junction point of the adjustable integral nut and machine thread portion of the pedicle screw is also rounded to reduce potential stress concentration. The screw is available in cancellous thread lengths from 25-50 mm, in 5 mm increments. **MATERIAL:** The AcroMed Pedicle Screw is manufactured from implant grade stainless steel conforming to ASTM F1314 specifications. 1 L1/7 'd 8160 'oN Wd02:ε 9661 '8 'AON {1} 2 of 2 # INDICATIONS: The AcroMed Pedicle Screw is designed to be utilized with the ISOLA Spine System (K944737). The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft and intended to be removed after solid fusion is attained. The ISOLA Spinal System, when not used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft and intended to be removed after solid fusion is attained. The ISOLA Spinal System, when not used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft and intended to be removed after solid fusion is attained. ## PERFORMANCE DATA: Static and fatigue testing show the AcroMed pedicle screws (4.75 mm) to perform consistently with previously cleared components. ## SUBSTANTIAL EQUIVALENCE: The AcroMed 4.75 mm diameter pedicle screw is equivalent to other AcroMed pedicle screws as cleared under K951116. L1/S d 8160°N Wd02:ε 96618 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K963639](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K963639) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com