Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart D — Prosthetic Devices](/submissions/OR/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 888.3040](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3040) → QSR — Sacroiliac Screw Placement Guide

# QSR · Sacroiliac Screw Placement Guide

_Orthopedic · 21 CFR 888.3040 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/QSR

## Overview

- **Product Code:** QSR
- **Device Name:** Sacroiliac Screw Placement Guide
- **Regulation:** [21 CFR 888.3040](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/888.3040)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)

## Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K220888](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/QSR/K220888.md) | MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides | Medacta International S.A. | May 24, 2022 | SESE |

## Top Applicants

- Medacta International S.A. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/QSR](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/QSR)

**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