Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart E — Surgical Devices](/submissions/OR/subpart-e%E2%80%94surgical-devices) → [21 CFR 888.4200](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4200) → KIH — Dispenser, Cement

# KIH · Dispenser, Cement

_Orthopedic · 21 CFR 888.4200 · Class 1_

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

## Overview

- **Product Code:** KIH
- **Device Name:** Dispenser, Cement
- **Regulation:** [21 CFR 888.4200](/submissions/OR/subpart-e%E2%80%94surgical-devices/888.4200)
- **Device Class:** 1
- **Review Panel:** [Orthopedic](/submissions/OR)

## Identification

A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (§ 888.3027) into surgical sites.

## 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 (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K042591](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KIH/K042591.md) | SMARTMIX PRE-FILLED MIXING SYSTEM | DePuy Orthopaedics, Inc. | Oct 22, 2004 | SESE |
| [K943906](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KIH/K943906.md) | P.F.C. CEMENT PRESSURIZING SYSTEM | Johnson & Johnson Professionals, Inc. | Dec 21, 1994 | SESE |
| [K897134](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KIH/K897134.md) | CMW CEMENT PRESSURISATION SYSTEM | Dentsply Intl. | Mar 2, 1990 | SESE |
| [K851881](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KIH/K851881.md) | ORTHOPEADIC CEMENT DELIVERY SYSTEM | Dentsply Intl. | Jun 13, 1985 | SESE |
| [K840046](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KIH/K840046.md) | PRESSURIZING/SCAVENGING ACRYLIC CEMENT | Precision Medical Devices, Inc. | Feb 9, 1984 | SESE |
| [K833675](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KIH/K833675.md) | BRIGHAM TIBIAL CEMENT PRESSURIZER | Howmedica Corp. | Dec 12, 1983 | SESE |
| [K811317](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KIH/K811317.md) | HOWMEDICA FEMORAL PRESSURING SEAL | Howmedica Corp. | May 29, 1981 | SESE |
| [K801388](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KIH/K801388.md) | OH-HARRIS | Johnson & Johnson Professionals, Inc. | Jul 28, 1980 | SESE |
| [K790275](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KIH/K790275.md) | GUN, EXETER CEMENT | Howmedica Corp. | Feb 21, 1979 | SESE |
| [K781955](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KIH/K781955.md) | GUN, CEMENT | Depuy, Inc. | Dec 4, 1978 | SESE |
| [K780266](https://fda.innolitics.com/submissions/OR/subpart-e%E2%80%94surgical-devices/KIH/K780266.md) | BONE CEMENT APPLICATOR | Zimmer, Inc. | Feb 28, 1978 | SESE |

## Top Applicants

- Howmedica Corp. — 3 clearances
- Dentsply Intl. — 2 clearances
- Johnson & Johnson Professionals, Inc. — 2 clearances
- DePuy Orthopaedics, Inc. — 1 clearance
- Depuy, Inc. — 1 clearance

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

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