# K053384: Fixature Microthread Osseospeed, a Component of the Astra Tech Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Astra Tech, Inc.
- Decided: Mar 24, 2006 after 109 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
528 later devices descend from it; 12 cite it directly.
0 of 529 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Fixture OsseoSpeed: named in the summary without a submission number
- (no number) TiUnite implant: named in the summary without a submission number

## Most influential descendants
- K070833: Atlantis Abutment for Astra Implant (2007), 357 descendants of its own
- K081666: Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 Implants (2008), 337 descendants of its own
- K100152: Sirona Cad/Cam System (2010), 240 descendants of its own
- K101732: Astra Tech Implant System (2011), 214 descendants of its own
- K071946: Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra Implants (2007), 209 descendants of its own

## Indications for use
Fixture MicroThreadTM OsseoSpeed TM is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla where immediate implant stability may be obtained.. The device may be used equally well in a single-stage ) or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded after implantation where immediate implant stability may be obtained. The fluoride-modified surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. Fixture MicroThread OsseoSpeed is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations.

Source page: https://510kreport.com/device/K053384
Methodology: https://510kreport.com/methodology