Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart E — Surgical Devices](/submissions/OR/subpart-e%E2%80%94surgical-devices) → [21 CFR 888.4800](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4800) → HWT — Template

# HWT · Template

_Orthopedic · 21 CFR 888.4800 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWT

## Overview

- **Product Code:** HWT
- **Device Name:** Template
- **Regulation:** [21 CFR 888.4800](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4800)
- **Device Class:** 1
- **Review Panel:** [Orthopedic](/submissions/OR)

## Identification

A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K974406](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWT/K974406.md) | ORTHOPLAN | Ortho-Graphics, Inc. | Feb 18, 1998 | SESE |
| [K960685](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWT/K960685.md) | ORTHODOC PREOPERATIVE PLANNER MODEL 500 | Integrated Surgical Systems, Inc. | Jan 17, 1997 | SESE |
| [K894228](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWT/K894228.md) | KRONNER SPHERICAL CUTTERS | Kronner Medical | Jul 23, 1990 | SESE |
| [K870843](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWT/K870843.md) | SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA | Warsaw Orthopedic, Inc. | May 27, 1987 | SESE |
| [K871323](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWT/K871323.md) | ARTHROSCOPIC MENISCAL SUTURE SYSTEM | Orthopedic Systems, Inc. | May 1, 1987 | SESE |
| [K830360](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWT/K830360.md) | 3M OSTEOTOMY GUIDE | 3M Company | Mar 1, 1983 | SESE |
| [K811205](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWT/K811205.md) | MOLDED POLYSULFONE TRIAL PROSTHESIS | Shannon Group | May 21, 1981 | SESE |
| [K781091](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWT/K781091.md) | KNEE INSTRUMENTATION, CONDYLAR | Biomet, Inc. | Jul 17, 1978 | SESE |
| [K771710](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWT/K771710.md) | WORRELL PATELLA TEMPLATE | Depuy, Inc. | Oct 6, 1977 | SESE |
| [K771709](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWT/K771709.md) | WORRELL TRIAL PATELLA | Depuy, Inc. | Oct 6, 1977 | SESE |

## Top Applicants

- Depuy, Inc. — 2 clearances
- 3M Company — 1 clearance
- Biomet, Inc. — 1 clearance
- Integrated Surgical Systems, Inc. — 1 clearance
- Kronner Medical — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWT](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/HWT)

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