KLS Martin IPS Distraction
510(k) K220050
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK220050 | Date11 Aug 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MQN
- FDA applicant
- KLS Martin L.P.
- Device class
- Class II
- Regulation
- 21 CFR Part 872.4760
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The KLS Martin IPS Distraction is an External Mandibular Fixator and/or Distractor, a Class II medical device designed for distraction osteogenesis in dental applications. It facilitates controlled bone lengthening and stabilization, enabling precise correction of mandibular deformities through gradual distraction techniques. The system includes modular components tailored for patient-specific use, ensuring adaptability to individual anatomical requirements.
This device is supplied as a reusable, non-sterile system intended for use in dental surgical settings. It is regulated under FDA 510(k) clearance (K220050) and falls under the Dental advisory committee classification. Multiple reference codes (e.g., 3000270450, 1032347) correspond to its regulatory and product categorization, adhering to 872.4760 for external fixation devices. No MRI safety or sterility requirements are specified in the data.
Other devices from KLS-Martin L.P.
Questions
AI-generated answers, 20 Sep 2026
What is the primary clinical purpose of the KLS Martin IPS Distraction system, and how does it achieve this?
The KLS Martin IPS Distraction is designed for distraction osteogenesis in dental applications, specifically to correct mandibular deformities. It achieves this through controlled bone lengthening and stabilization, using gradual distraction techniques to gradually lengthen the jawbone over time. The modular components allow for customization to fit individual patient anatomy, ensuring precise adjustments during treatment.
Is the KLS Martin IPS Distraction system reusable or single-use, and what are the sterility requirements?
The system is reusable and non-sterile, intended for use in dental surgical settings. Since it is not sterile, it must be properly cleaned and sterilized between uses in accordance with clinical protocols. No specific sterility requirements are mentioned in the provided data, so adherence to standard surgical cleaning and sterilization practices is recommended.
How is the device regulated in the U.S., and what does the FDA classification imply about its oversight?
The KLS Martin IPS Distraction is classified as a Class II medical device under FDA regulations and has received 510(k) clearance (K220050). This classification means it is subject to premarket notification requirements and is regulated under the Dental advisory committee (DE), ensuring it meets performance standards for external fixation devices (regulated under 872.4760). The clearance indicates it is deemed substantially equivalent to a predicate device, meaning it shares the same intended use and technological characteristics.
Are there any specific storage or handling considerations for the KLS Martin IPS Distraction system?
While the data does not specify detailed storage conditions, as a reusable, non-sterile system, it should be stored in a clean, dry environment to prevent contamination. Before use, components must be thoroughly cleaned and sterilized according to standard surgical protocols. Since it is modular and patient-specific, proper organization and inventory management are recommended to ensure correct assembly and compatibility for each case.