Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Stryker Trauma GmbH · Predicate Candidate Screening

7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

106 daysmedian FDA review time
127 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K200869Gamma3 SystemStryker Trauma GmbH2020-07-221120
K193308T2 Alpha Tibia Nailing System, IMN Screws SystemStryker Trauma GmbH2020-02-23860
K191271T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha TibiStryker Trauma GmbH2019-06-11290
K180436T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PStryker Trauma GmbH2018-06-061060
K172774T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws SyStryker Trauma GmbH2018-01-121200
K170418Stryker SonicPin SystemStryker Trauma GmbH2017-06-201270
K143063Stryker SonicPin System, Stryker SonicAnchor SystemStryker Trauma GmbH2015-01-27950

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda