Atlas FDA

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

Stryker GmbH — Predicate Candidate Screening

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

107 daysmedian FDA review time
185 days90th percentile
55clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261481Pangea Femur Reconstruction SystemStryker GmbH2026-06-29550
K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur ReconStryker GmbH2026-02-03760
K253202Hoffmann LRF SystemStryker GmbH2025-12-19840
K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 NailiStryker GmbH2025-08-201060
K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH2025-08-132040
K242445Pangea Platform; Pangea Femur Plating System; Pangea HumerusStryker GmbH2024-10-06510
K233919VariAx 2 Distal Radius SystemStryker GmbH2024-03-251030
K233741Hoffmann LRF SystemStryker GmbH2023-12-21290
K231262Pangea Femur Plating System, Pangea Fibula Plating System, PStryker GmbH2023-08-181090
K231257Pangea Utility Plating System, Pangea PlatformStryker GmbH2023-08-181090
K230512Gamma4 SystemStryker GmbH2023-06-091050
K222381PeriPRO™ Femur System, Variable Angle Fixation System, AxSOSStryker GmbH2023-04-272650
K223772PRO Plating System, Stryker Trauma Pelvic Set (Matta)Stryker GmbH2023-04-071120
K222309Gamma4 SystemStryker GmbH2022-11-151060
K221346Stryker VariAx 2 MIS CalcaneusStryker GmbH2022-07-08600
K210582EasyClip® and EasyClip® XpressStryker GmbH2022-06-104690
K220319Asnis III Cannulated Screw System, Asnis PRO Cannulated ScreStryker GmbH2022-06-101270
K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial NStryker GmbH2022-02-111291
K212581VariAx 2 Distal Radius System, VariAx 2 Distal Ulna SystemStryker GmbH2022-01-191560
K213199Asnis® III Cannulated Screw System and Asnis® PRO CannulatedStryker GmbH2022-01-111040
K211508Steinmann Pins and Kirschner WiresStryker GmbH2021-10-051440
K210861ReUnion Reversible Fracture System (RFX), ReUnion Reverse ShStryker GmbH2021-09-031640
K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur AntStryker GmbH2021-02-26590
K203568Hoffmann LRF SystemStryker GmbH2021-02-01560
K202749ADAPT for Gamma3Stryker GmbH2020-12-18880
K202289ReUnion Reversible Fracture System (RFX), ReUnion Reverse ShStryker GmbH2020-12-161260
K201715Smart Toe II, X FuseStryker GmbH2020-08-05430
K200880T2 Tibial Nailing System, T2 Femoral Nail System, T2 SupracoStryker GmbH2020-07-01900
K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH2020-06-051080
K193366T2 ICFStryker GmbH2020-03-201070
K192675VariAx FootStryker GmbH2019-11-22570
K191412VariAx 2 System, VariAx 2 Mini Fragment SystemStryker GmbH2019-08-23870
K183104Mini Cannulated Headed and Headless Screw SetStryker GmbH2019-06-102140
K183039ReUnion Reversible Fracture System (RFX), ReUnion Reverse ShStryker GmbH2019-02-151060
K182968Hoffmann LRF SystemStryker GmbH2019-01-25910
K181848ADAPT for Gamma3, Gamma3Stryker GmbH2018-10-12930
K181091AxSOS 3 TiStryker GmbH2018-10-111700
K181742ReUnion Reversible Fracture System (RFX), ReUnion Reverse ShStryker GmbH2018-09-27870
K180500VariAx 2 SystemStryker GmbH2018-06-04980
K173946ADAPT for Gamma3Stryker GmbH2018-05-021260
K172148Anchorage Bone Plating SystemStryker GmbH2018-03-192450
K172350AxSOS 3 TiStryker GmbH2017-12-151340
K173135VariAx 2 SystemStryker GmbH2017-11-27590
K170727VariAx 2 Compression Plating SystemStryker GmbH2017-06-221050
K170771VariAx 2 Foot SystemStryker GmbH2017-05-08550
K163656Hoffmann LRF SystemStryker GmbH2017-04-141120
K162841VariAx Distal Radius Plating System, VariAx 2 SystemStryker GmbH2017-02-211330
K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH2017-02-031560
K161863ReUnion Reversible Fracture System (RFX), ReUnion Reverse ShStryker GmbH2016-11-231400
K161753Hoffman LRF SystemStryker GmbH2016-11-151440

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