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 Aug 18, 2025 as substantially equivalent to K163361 (Globus Medical, Inc., 2017) and 4 other predicates after a 125-day review. Its family tree reaches back 18 generations to 1996.
- Decided
- Aug 18, 2025
- Review
- 125 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 18 generations to K962616 (1996). 316 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 18 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 14 generations between
- 3 generations backK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
- 2 generations backK212433 Anthem Fracture SystemGlobus Medical, Inc. · 2021
- 1 generation backK213591 ANTHEM® Fracture SystemGlobus Medical, Inc. · 2022
- This deviceK251161 ANTHEM® Fracture SystemGlobus Medical, Inc. · 2025
Show all 18 generations
- Root · 18 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 17 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 16 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 15 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 14 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 13 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 12 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 11 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
- 10 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
- 9 generations backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
- 8 generations backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- 7 generations backK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- 6 generations backK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- 5 generations backK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- 4 generations backK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- 3 generations backK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
- 2 generations backK212433 Anthem Fracture SystemGlobus Medical, Inc. · 2021
- 1 generation backK213591 ANTHEM® Fracture SystemGlobus Medical, Inc. · 2022
- This deviceK251161 ANTHEM® Fracture SystemGlobus Medical, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −17 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −16 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −15 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −14 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −13 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −12 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −11 | K061352 | Peri-Loc Periarticular Locked Plating System for the Upper Extremity | Smith & Nephew, Inc. | 2006 | — |
| −10 | K082516 | Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws | Smith & Nephew, Inc. | 2008 | — |
| −9 | K083032 | Peri-Loc Bone Plating and Screw System | Smith & Nephew, Inc. | 2009 | 2 |
| −8 | K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | Smith & Nephew, Inc. | 2013 | — |
| −7 | K140814 | Evos Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| −6 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| −5 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| −4 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
| −3 | K202496 | ANTHEM Fracture System | Globus Medical, Inc. | 2020 | — |
| −2 | K212433 | Anthem Fracture System | Globus Medical, Inc. | 2021 | — |
| −1 | K213591 | ANTHEM® Fracture System | Globus Medical, Inc. | 2022 | — |
| 0 (this device) | 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 | 7 | 0 |
| 2013 | 4 | 0 |
| 2014 | 6 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K163361 | ANTHEM™ Fracture SystemSummary page 5…ner Product Code: HRS (primary), HWC Regulatory Class: II, Panel Code: 87 Primary Predicate: ANTHEM® Fracture System (K163361) Additional Predicates: ANTHEM® Fracture System (K202496, K212433, K213591)… | 2017 |
| * | K202496 | ANTHEM Fracture SystemSummary page 5…Regulatory Class: II, Panel Code: 87 Primary Predicate: ANTHEM® Fracture System (K163361) Additional Predicates: ANTHEM® Fracture System (K202496, K212433, K213591) Synthes Variable Angle LCP™ Elbow System (K120070) Re… | 2020 |
| * | K212433 | Anthem Fracture SystemSummary page 5…Regulatory Class: II, Panel Code: 87 Primary Predicate: ANTHEM® Fracture System (K163361) Additional Predicates: ANTHEM® Fracture System (K202496, K212433, K213591) Synthes Variable Angle LCP™ Elbow System (K120070) Reference D… | 2021 |
| * | K213591 | ANTHEM® Fracture SystemSummary page 5…de: 87 Primary Predicate: ANTHEM® Fracture System (K163361) Additional Predicates: ANTHEM® Fracture System (K202496, K212433, K213591) Synthes Variable Angle LCP™ Elbow System (K120070) Reference Devices: HEDRON® Cervical & L… | 2022 |
| * | K120070 | Synthes Variable Angle LCP Elbow SystemSummary page 5…al Predicates: ANTHEM® Fracture System (K202496, K212433, K213591) Synthes Variable Angle LCP™ Elbow System (K120070) Reference Devices: HEDRON® Cervical & Lumbar Spacers, SABLE® Expandable Spacer (K222270)… | 2012 |
| † | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 54 of the 316 ancestors have a recall of any class.
- 4 other devices also cite its predicate K163361.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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, distal…
Read the full statement (233 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, distal humerus, proximal ulna, and proximal radius 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, distal humerus, proximal ulna, proximal radius, 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 as stated in the FDA summary.
https://510kreport.com/device/K251161 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251161: 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/K251161
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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