510(k) · Cleared
ClearedANTHEM® Fracture System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · HRS Plate, Fixation, Bone
Cleared on Jan 26, 2022 as substantially equivalent to K202496 (Globus Medical, Inc., 2020) and 2 other predicates after a 75-day review. Its family tree reaches back 17 generations to 1996. 5 later devices descend from it.
- Decided
- Jan 26, 2022
- Review
- 75 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K962616 (1996). 314 ancestors in all, the oldest K792022 (1979). 5 later devices descend from it, 2 citing it directly.
- Root · 17 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations between
- 3 generations backK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- 2 generations backK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
- 1 generation backK212433 Anthem Fracture SystemGlobus Medical, Inc. · 2021
- This deviceK213591 ANTHEM® Fracture SystemGlobus Medical, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK232652 Anatomical Plating System (various)Tyber Medical, LLC · 2023 · Recalled
- Descendant · 2 generations on · 2 of its ownK241218 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024
- Descendant · 2 generations on · 1 of its ownK242486 Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK261207 Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026
- Descendant · cites it directly · 0 of its ownK251161 ANTHEM® Fracture SystemGlobus Medical, Inc. · 2025
Show all 17 generations
- Root · 17 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 16 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 15 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 14 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 13 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 12 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 11 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 10 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 9 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- 8 generations backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
- 7 generations backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- 6 generations backK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- 5 generations backK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- 4 generations backK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- 3 generations backK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- 2 generations backK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
- 1 generation backK212433 Anthem Fracture SystemGlobus Medical, Inc. · 2021
- This deviceK213591 ANTHEM® Fracture SystemGlobus Medical, Inc. · 2022
Most influential descendants
Showing 5 of 5 · See all- K232652Anatomical Plating System (various)Tyber Medical, LLC · 2023 · cites it directly3descendants
- K241218Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2024 · 2 generations on2descendants
- K242486Tyber Medical Anatomical Plating SystemTyber Medical, LLC · 2025 · 2 generations on1descendant
- K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC · 2026 · 3 generations on0descendants
- K251161ANTHEM® Fracture SystemGlobus Medical, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −16 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −15 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −14 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −13 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −12 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −11 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −10 | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | 2006 | — |
| −9 | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | Smith & Nephew, Inc. | 2008 | — |
| −8 | K083032 | Peri-Loc Bone Plating and Screw System | Smith & Nephew, Inc. | 2009 | 2 |
| −7 | K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | Smith & Nephew, Inc. | 2013 | — |
| −6 | K140814 | Evos Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| −5 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| −4 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| −3 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
| −2 | K202496 | ANTHEM Fracture System | Globus Medical, Inc. | 2020 | — |
| −1 | K212433 | Anthem Fracture System | Globus Medical, Inc. | 2021 | — |
| 0 (this device) | K213591 | ANTHEM® Fracture System | Globus Medical, Inc. | 2022 | — |
| +1 | K232652 | Anatomical Plating System (various) | Tyber Medical, LLC | 2023 | 20 |
| +2 | K241218 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2024 | — |
| +2 | K242486 | Tyber Medical Anatomical Plating System | Tyber Medical, LLC | 2025 | — |
| +3 | K261207 | Exalta Proximal Tibia Plating System | Tyber Medical, LLC | 2026 | — |
| +1 | K251161 | ANTHEM® Fracture System | Globus Medical, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 2 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 14 | 0 |
| 1996 | 21 | 0 |
| 1997 | 11 | 0 |
| 1998 | 12 | 0 |
| 1999 | 11 | 0 |
| 2000 | 15 | 0 |
| 2001 | 22 | 0 |
| 2002 | 9 | 0 |
| 2003 | 15 | 0 |
| 2004 | 22 | 0 |
| 2005 | 20 | 0 |
| 2006 | 19 | 0 |
| 2007 | 11 | 0 |
| 2008 | 13 | 0 |
| 2009 | 12 | 0 |
| 2010 | 14 | 0 |
| 2011 | 8 | 0 |
| 2012 | 6 | 0 |
| 2013 | 4 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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 HRS? 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K202496 | ANTHEM Fracture SystemSummary page 4…fastener Product Code: HRS (primary), HWC, HTN Regulatory Class: II Primary Predicate: ANTHEM® Fracture System (K202496) Additional Predicates: ANTHEM® Fracture System (K212433) Stryker AxSOS 3 (K172350) Purpose: The… | 2020 |
| * | K212433 | Anthem Fracture SystemSummary page 4…mary), HWC, HTN Regulatory Class: II Primary Predicate: ANTHEM® Fracture System (K202496) Additional Predicates: ANTHEM® Fracture System (K212433) Stryker AxSOS 3 (K172350) Purpose: The purpose of this submission is to request clearance for ANTHEM® Dist… | 2021 |
| * | K172350 | AxSOS 3 TiSummary page 4…Class: II Primary Predicate: ANTHEM® Fracture System (K202496) Additional Predicates: ANTHEM® Fracture System (K212433) Stryker AxSOS 3 (K172350) Purpose: The purpose of this submission is to request clearance for ANTHEM® Distal Femur plates, screws, and washers, as a line… | 2017 |
What descends from it? (5)
2 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 26 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 53 of the 314 ancestors have a recall of any class.
- Of its descendants, K232652 (Tyber Medical, LLC, 2023) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K202496.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The ANTHEM® Fracture System is indicated for fixation of fractures, osteotomies, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, femur, tibia, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint. Distal femur plates…
Read the full statement (220 words)
The ANTHEM® Fracture System is indicated for fixation of fractures, osteotomies, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, femur, tibia, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint. Distal femur plates are indicated for diaphyseal, metaphyseal, epiphyseal, supracondylar, intra-articular, extra-articular, condylar, periprosthetic, and comminuted fractures, and for non-unions and malunions. Mini fragment plates are also indicated for fixation of fractures of the acetabulum, patella, and bone fragments, replantation, malunions and nonunion, and for non-load bearing stabilization and reduction of long bone fragments. Metaphyseal plates are indicated for non-load bearing stabilization and reduction of long bone fragments, and for fixation of bones including the radius and ulna.
In addition to adult patients, small fragment, mini fragment, proximal tibia, clavicle, metaphyseal, and distal fibula plates are indicated for use in infant, child, and adolescent pediatric subgroups and small stature adults. Distal femur plates are indicated for use in the diaphyseal and metaphyseal areas of long bones in adolescent pediatric patients. Distal radius, distal tibia, metaphyseal, and mini fragment plates are indicated for use in adolescents (12-21 years of age). Plating can be used in patients with osteopenic bone.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213591: ANTHEM® Fracture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213591
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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