510(k) · Cleared
ClearedT2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker GmbH · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jul 1, 2020 as substantially equivalent to K003018 (Howmedica Osteonics Corp., 2000) and 11 other predicates after a 90-day review. Its family tree reaches back 6 generations to 1995. 11 later devices descend from it.
- Decided
- Jul 1, 2020
- Review
- 90 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 6 generations to K951740 (1995). 27 ancestors in all, the oldest K923580 (1993). 11 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
- 5 generations backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
- 4 generations backK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
- 3 generations backK061019 Trigen Meta-Nail Retrograde Femoral and Tibial NailsSmith & Nephew, Inc. · 2006 · Recalled
- 2 generations backK111667 Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 2011 · Recalled
- 1 generation backK131365 T2 Tibial Nailing SystemStryker Trauma AG · 2013 · Recalled
- This deviceK200880 T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar…Stryker GmbH · 2020
- Descendant · cites it directly · 7 of its ownK203819 T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade…Stryker GmbH · 2021
- Descendant · 2 generations on · 3 of its ownK213328 Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing…Stryker GmbH · 2022 · Recalled
- Descendant · 2 generations on · 2 of its ownK250163 T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025
- Descendant · 3 generations on · 1 of its ownK253640 T2 Alpha Femur Retrograde Nailing System; Pangea Femur…Stryker GmbH · 2026
- Descendant · cites it directly · 1 of its ownK230088 Ankle Truss System (ATS)4Web Medical, Inc. · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K203819T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System…Stryker GmbH · 2021 · cites it directly7descendants
- K213328Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing SystemStryker GmbH · 2022 · 2 generations on3descendants
- K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH · 2025 · 2 generations on2descendants
- K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH · 2026 · 3 generations on1descendant
- K230088Ankle Truss System (ATS)4Web Medical, Inc. · 2024 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K951740 | Intramedulary Fixation Rod | Acu Med, Inc. | 1995 | 1 |
| −5 | K032722 | Trigen Straight Humeral Nail System | Smith & Nephew, Inc. | 2003 | — |
| −4 | K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial Nails | Smith & Nephew, Inc. | 2005 | — |
| −3 | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial Nails | Smith & Nephew, Inc. | 2006 | 1 |
| −2 | K111667 | Synthes Suprapatellar Insertion Instruments | Synthes (Usa) | 2011 | 1 |
| −1 | K131365 | T2 Tibial Nailing System | Stryker Trauma AG | 2013 | 4 |
| 0 (this device) | K200880 | T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail… | Stryker GmbH | 2020 | — |
| +1 | K203819 | T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF… | Stryker GmbH | 2021 | — |
| +2 | K213328 | Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System | Stryker GmbH | 2022 | 1 |
| +2 | K250163 | T2 Alpha Femur Retrograde Nailing System | Stryker GmbH | 2025 | — |
| +3 | K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | Stryker GmbH | 2026 | — |
| +1 | K230088 | Ankle Truss System (ATS) | 4Web Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HSB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (12)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K003018 | Titan Tibial NailSummary page 11…HSB (Rod, fixation, intramedullary and accessories) Device Class: Class II Predicate Device: T2 Tibial Nailing System – K003018 and K131365 T2 Femoral Nail System – K081152, K021744 and K010801… | 2000 |
| * | K131365 | T2 Tibial Nailing SystemSummary page 11…, fixation, intramedullary and accessories) Device Class: Class II Predicate Device: T2 Tibial Nailing System – K003018 and K131365 T2 Femoral Nail System – K081152, K021744 and K010801… | 2013 |
| * | K081152 | T2 Femoral NailSummary page 11…Class II Predicate Device: T2 Tibial Nailing System – K003018 and K131365 T2 Femoral Nail System – K081152, K021744 and K010801 Synthes Solid Femoral Nail - K923580… | 2008 |
| * | K021744 | T2 Femoral NailSummary page 11…Class II Predicate Device: T2 Tibial Nailing System – K003018 and K131365 T2 Femoral Nail System – K081152, K021744 and K010801 Synthes Solid Femoral Nail - K923580 T2 S… | 2002 |
| * | K010801 | T2 Femoral NailSummary page 11…Predicate Device: T2 Tibial Nailing System – K003018 and K131365 T2 Femoral Nail System – K081152, K021744 and K010801 Synthes Solid Femoral Nail - K923580 T2 Supracondylar… | 2001 |
| * | K923580 | Synthes TI-6AI-7NB Unreamed Femoral NailSummary page 11…nd K131365 T2 Femoral Nail System – K081152, K021744 and K010801 Synthes Solid Femoral Nail - K923580 T2 Supracondylar Nail System – K023267 T2 Recon Nail… | 1993 |
| * | K023267 | T2 Supracondylar Nail SystemSummary page 11…1152, K021744 and K010801 Synthes Solid Femoral Nail - K923580 T2 Supracondylar Nail System – K023267 T2 Recon Nail System – K102992 and K032898 T2 Greater… | 2002 |
| * | K102992 | T2 Recon Nail, R1500, Left/Right 125 Degrees / 120 Degrees / 130 DegreesSummary page 11…es Solid Femoral Nail - K923580 T2 Supracondylar Nail System – K023267 T2 Recon Nail System – K102992 and K032898 T2 Greater Trochanter Nail (GTN) – K101438… | 2010 |
| * | K032898 | T2 Recon Nail SystemSummary page 11…oral Nail - K923580 T2 Supracondylar Nail System – K023267 T2 Recon Nail System – K102992 and K032898 T2 Greater Trochanter Nail (GTN) – K101438 T2 Ankle A… | 2003 |
| * | K101438 | T2 Greater Trochanter NailSummary page 11…ystem – K023267 T2 Recon Nail System – K102992 and K032898 T2 Greater Trochanter Nail (GTN) – K101438 T2 Ankle Arthrodesis Nail - K051590 T2 Arthrodesis Na… | 2010 |
| * | K051590 | T2 Ankle Arthrodesis NailSummary page 11…– K102992 and K032898 T2 Greater Trochanter Nail (GTN) – K101438 T2 Ankle Arthrodesis Nail - K051590 T2 Arthrodesis Nail System – K020384 Description T2 Tibial Nailing System The T2 Tibial Na… | 2005 |
| * | K020384 | T2 Arthrodesis Nail SystemSummary page 11…chanter Nail (GTN) – K101438 T2 Ankle Arthrodesis Nail - K051590 T2 Arthrodesis Nail System – K020384 Description T2 Tibial Nailing System The T2 Tibial Nailing System is a cylindrical tube manufactured from titanium alloy and sli… | 2002 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 5 companies; a new generation was cleared every 5.5 years on median.
- 18 of the 27 ancestors have a recall of any class.
- Of its descendants, K203819 (Stryker GmbH, 2021) has gone furthest, with 7 descendants of its own.
- 12 other devices also cite its predicate K003018.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
The T2 Tibial Nailing System is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked. The T2 Tibial Nailing System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following: • Open and closed tibial fractures •…
Read the full statement (501 words)
The T2 Tibial Nailing System is intended to provide temporary stabilization of various types of fractures, malunions and nonunion of the tibia. The nails are inserted using an opened or closed technique and can be statically, dynamically and compressed locked.
The T2 Tibial Nailing System is indicated for long bone fracture fixation, specifically tibial fracture fixation, which may include the following:
• Open and closed tibial fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures, and tumor resections
• Nonunion and malunion
The T2 Femoral Nail is indicated for long bone fracture fixation specifically femoral fracture fixation which may include the following:
• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures, and tumor resections
• Supracondylar fractures, including those with intra-articular extension
• Ipsilateral femur fractures
• Fractures proximal to a total knee arthroplasty
• Fractures distal to hip joint
• Nonunions and malunions
The T2 Supracondylar Nail System is indicated for:
• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures, and tumor resections
• Supracondylar fractures including those with intra-articular extension
• Fractures distal to total hip prosthesis
• Nonunions and malunions
The T2 Recon Nail is indicated for:
• Subtrochanteric fractures
• Intertrochanteric fractures
• Ipsilateral neck/shaft fractures
• Comminuted proximal femoral shaft fractures
• Femoral fixation required as a result of pathological disease
• Temporary stabilization of fractures of the femoral shaft – ranging from the femoral neck to the supracondylar regions of the femur.
The T2 Greater Trochanter Nail is indicated for long bone fracture fixation, which may include the following:
• Open and closed femoral fractures
• Pseudarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures, and tumor resections
• Ipsilateral femur fractures
• Fractures proximal to a total knee arthroplasty
• Nonunions and malunions.
The T2 Ankle Arthrodesis Nail is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:
• Post-traumatic or primary Arthrosis
• Previously infected arthrosis (second degree)
• Revision of Failed Ankle Arthrodesis
• Failed Total Ankle Replacement
• Avascular Necrosis of the Talus (requiring tibiocalcaneal arthrodesis)
• Neuroarthropathy or Neuromuscular Deformity or other neuromuscular disease with severe deformity or instability of the ankle
• Rheumatoid Arthritis with severe deformity such as rheumatoid hindfoot
• Osteoarthritis
• Nonunions or Pseudarthrosis of hindfoot and distal tibia
• Malunited tibial pilon fracture
• Charcot foot
• Severe endstage degenerative arthritis
• Severe defects after tumor resection
• Pantalar arthrodesis
The T2 Arthrodesis Nail is intended for long bone internal fixation, which may include the following:
• Aseptic failed total knee arthroplasty
• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathological fractures, impending pathological fractures, and tumor resections
• Ipsilateral femur fractures
• Failed external fixation, nonunions and malunions
• Periarticular fractures where repair is not possible
• Knee arthrodesis
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200880 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200880: T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200880
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026