510(k) Report

510(k) · Cleared

Cleared

ANTHEM™ Fracture System

K163361510(k) TraditionalCleared Apr 7, 2017128-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Globus Medical, Inc. · HRS Plate, Fixation, Bone

Cleared on Apr 7, 2017 as substantially equivalent to K073460 (Synthes (Usa), 2008) and 25 other predicates after a 128-day review. Its family tree reaches back 12 generations to 1996. 14 later devices descend from it.

Decided
Apr 7, 2017
Review
128 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
26

Its longest line of descent runs back 12 generations to K962616 (1996). 229 ancestors in all, the oldest K792022 (1979). 14 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2016: 1 other ancestor2015: 2 other ancestors2014: 3 other ancestors2011: 5 other ancestors2010: 7 other ancestors2009: 9 other ancestors2008: 8 other ancestors2007: 7 other ancestors2006: 11 other ancestors2004: 19 other ancestors2001: 19 other ancestors2000: 13 other ancestors1995: 12 other ancestors2012: 1 other ancestor2005: 13 other ancestors2003: 12 other ancestors2002: 9 other ancestors1999: 10 other ancestors1998: 10 other ancestors1996: 18 other ancestors1997: 9 other ancestors1994: 4 other ancestors1991: 2 other ancestors1990: 4 other ancestors1989: 2 other ancestors1988: 1 other ancestor1982: 1 other ancestor1993: 3 other ancestors1992: 1 other ancestor1979: 1 other ancestor2018: 2 descendants cleared2017: 1 descendant cleared2020: 1 descendant cleared2025: 2 descendants cleared2024: 4 descendants cleared2021: 1 descendant cleared2022: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant clearedK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×3: 3 generations cleared close together, K023007 (2002), K030198 (2003), K032705 (2003) ×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K061352 · Peri-Loc Periarticular Locked Plating System for the Upper Extremity · Smith & Nephew, Inc. · 2006×2: 2 generations cleared close together, K082516 (2008), K083032 (2009) K123055 · Smith & Nephew, Inc Screw and Plate System Instrumentation · Smith & Nephew, Inc. · 2013K140814 · Evos Mini-Fragment Plating System · Smith & Nephew, Inc. · 2014 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 23 other ancestors2 generations back: 47 other ancestors3 generations back: 59 other ancestors4 generations back: 44 other ancestors5 generations back: 29 other ancestors6 generations back: 12 other ancestors7 generations back: 3 other ancestors 1 generation forward: 5 descendants2 generations forward: 4 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant K140814 · Evos Mini-Fragment Plating System · Smith & Nephew, Inc. · 2014 · recalledK123055 · Smith & Nephew, Inc Screw and Plate System Instrumentation · Smith & Nephew, Inc. · 2013K083032 · Peri-Loc Bone Plating and Screw System · Smith & Nephew, Inc. · 2009 · recalledK082516 · Peri-Loc Periarticular Locked Plating System Hexalobular Bone Screws · Smith & Nephew, Inc. · 2008K061352 · Peri-Loc Periarticular Locked Plating System for the Upper Extremity · Smith & Nephew, Inc. · 2006K051735 · Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity · Smith & Nephew, Inc. · 2005K050932 · Distal Volar Radius Anatomical Plate System · Hand Innovations, Inc. · 2005 · recalledK032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K030198 · Hand Innovations, Inc. Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003K023007 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2002K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998K962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996−10−50+5
  1. Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 8 generations between
  3. 3 generations backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
  4. 2 generations backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
  5. 1 generation backK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
  6. This deviceK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
  7. Descendant · cites it directly · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
  8. Descendant · cites it directly · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
  9. Descendant · cites it directly · 8 of its ownK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
  10. Descendant · 2 generations on · 7 of its ownK212433 Anthem Fracture SystemGlobus Medical, Inc. · 2021
  11. Descendant · 2 generations on · 5 of its ownK213591 ANTHEM® Fracture SystemGlobus Medical, Inc. · 2022
Show all 12 generations
  1. Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 5 generations backK061352 Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc. · 2006
  9. 4 generations backK082516 Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc. · 2008
  10. 3 generations backK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
  11. 2 generations backK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
  12. 1 generation backK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
  13. This deviceK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2017: 12018: 22020: 12021: 12022: 12023: 12024: 42025: 22026: 1
2017high 4 (2024) · low 0 (2019)2026

Most influential descendants

Showing 5 of 14 · See all
  • K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · cites it directly11descendants
  • K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · cites it directly10descendants
  • K202496ANTHEM Fracture SystemGlobus Medical, Inc. · 2020 · cites it directly8descendants
  • K212433Anthem Fracture SystemGlobus Medical, Inc. · 2021 · 2 generations on7descendants
  • K213591ANTHEM® Fracture SystemGlobus Medical, Inc. · 2022 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−11K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−10K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−9K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−8K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−7K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−6K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−5K061352Peri-Loc Periarticular Locked Plating System for the Upper ExtremitySmith & Nephew, Inc.2006—
−4K082516Peri-Loc Periarticular Locked Plating System Hexalobular Bone ScrewsSmith & Nephew, Inc.2008—
−3K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc.20092
−2K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc.2013—
−1K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc.20142
0 (this device)K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.2017—
+1K173166ANTHEM Fracture SystemGlobus Medical, Inc.2017—
+1K180554ANTHEM Fracture SystemGlobus Medical, Inc.2018—
+1K202496ANTHEM Fracture SystemGlobus Medical, Inc.2020—
+2K212433Anthem Fracture SystemGlobus Medical, Inc.2021—
+2K213591ANTHEM® Fracture SystemGlobus Medical, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198210
198810
198920
199040
199120
199210
199330
199440
1995120
1996180
199790
1998100
1999100
2000130
2001190
200290
2003120
2004190
2005130
2006110
200770
200880
200990
201070
201150
201210
201430
201520
201610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201820
202010
202110
202210
202310
202440
202520
202610
FIG. 1 — Lineage of K163361, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (26)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K073460Synthes 2.7 MM/3.5 MM LCP Distal Fibula Plates
Summary page 4
…fastener Product Code: HRS, HWC Regulatory Class: II Predicates: Synthes 2.7mm/3.5mm LCP Distal Fibula Plates (K073460) Arthrex Fracture System (K112437) Synthes Volar Distal Radius Plate (K092556, K982732)…
Synthes (Usa)2008—
*K112437Arthrex Fracture System
Summary page 4
…ode: HRS, HWC Regulatory Class: II Predicates: Synthes 2.7mm/3.5mm LCP Distal Fibula Plates (K073460) Arthrex Fracture System (K112437) Synthes Volar Distal Radius Plate (K092556, K982732) Stryker Anatomic Volar Plate (K133974)…
Arthrex, Inc.2011—
*K092556Synthes (Usa) 2.4MM VA-LCP Two-Column Narrow Volar Distal Radius
Summary page 4
…es: Synthes 2.7mm/3.5mm LCP Distal Fibula Plates (K073460) Arthrex Fracture System (K112437) Synthes Volar Distal Radius Plate (K092556, K982732) Stryker Anatomic Volar Plate (K133974) Skeletal Dynamics Geminus Volar Distal Radiu…
Synthes (Usa)20091
*K982732Synthes (Usa) Distal Radius Plate System (DRPS)
Summary page 4
…Synthes 2.7mm/3.5mm LCP Distal Fibula Plates (K073460) Arthrex Fracture System (K112437) Synthes Volar Distal Radius Plate (K092556, K982732) Stryker Anatomic Volar Plate (K133974) Skeletal Dynamics Geminus Volar Distal Radius Plate…
Synthes1998—
*K133974Variax Distal Radius Plating System
Summary page 4
…Arthrex Fracture System (K112437) Synthes Volar Distal Radius Plate (K092556, K982732) Stryker Anatomic Volar Plate (K133974) Skeletal Dynamics Geminus Volar Distal Radius Plate System (K111620) Tr…
Stryker Leibinger GmbH2014—
*K111620Skeletal Dynamics Geminus Volar Distal Radius Plate Model Standard 3 Hole Right…
Summary page 4
…556, K982732) Stryker Anatomic Volar Plate (K133974) Skeletal Dynamics Geminus Volar Distal Radius Plate System (K111620) Trimed Bearing Bridge Plate (K040112) Medartis Hook Plate (K142906) Synthe…
Skeletal Dynamics, LLC2011—
*K040112Trimed Bearing Plate; Trimed Volar Bearing Plate
Summary page 4
…late (K133974) Skeletal Dynamics Geminus Volar Distal Radius Plate System (K111620) Trimed Bearing Bridge Plate (K040112) Medartis Hook Plate (K142906) Synthes LCP Distal Radius System (K102694) S…
Tri-Med, Inc.2004—
*K142906APTUS Wrist 2.5 System
Summary page 4
…cs Geminus Volar Distal Radius Plate System (K111620) Trimed Bearing Bridge Plate (K040112) Medartis Hook Plate (K142906) Synthes LCP Distal Radius System (K102694) Synthes LCP Proximal Humerus Plates (K011815, K04…
Medartis AG2015—
*K1026942.4MM VA-LCP Dorsal Distal Radius Plates
Summary page 4
…tem (K111620) Trimed Bearing Bridge Plate (K040112) Medartis Hook Plate (K142906) Synthes LCP Distal Radius System (K102694) Synthes LCP Proximal Humerus Plates (K011815, K041860) Arthrex Humeral Fracture Plate (K0419…
Synthes (Usa)20103
*K011815Synthes LCP Proximal Humerus Plates
Summary page 4
…0112) Medartis Hook Plate (K142906) Synthes LCP Distal Radius System (K102694) Synthes LCP Proximal Humerus Plates (K011815, K041860) Arthrex Humeral Fracture Plate (K041965) Synthes 3.5mm LCP Periarticular Proximal H…
Synthes (Usa)2001—
*K041860Synthes (Usa) LCP Proximal Humerus Plates, Long
Summary page 4
…Medartis Hook Plate (K142906) Synthes LCP Distal Radius System (K102694) Synthes LCP Proximal Humerus Plates (K011815, K041860) Arthrex Humeral Fracture Plate (K041965) Synthes 3.5mm LCP Periarticular Proximal Humerus Pl…
Synthes (Usa)2004—
*K041965Arthrex Humeral Fracture Plates and Screws
Summary page 4
…Synthes LCP Distal Radius System (K102694) Synthes LCP Proximal Humerus Plates (K011815, K041860) Arthrex Humeral Fracture Plate (K041965) Synthes 3.5mm LCP Periarticular Proximal Humerus Plates (K082625) Biome…
Arthrex, Inc.2004—
*K082625Synthes (Usa) 3.5MM LCP Periarticular Proximal Humerus Plates
Summary page 4
…1815, K041860) Arthrex Humeral Fracture Plate (K041965) Synthes 3.5mm LCP Periarticular Proximal Humerus Plates (K082625) Biomet Proximal Humerus Plating System (K143697) Synthes Small Fragment DCL System (K000684)…
Synthes (Usa)20081
*K143697Biomet Proximal Humerus Plating System
Summary page 4
…41965) Synthes 3.5mm LCP Periarticular Proximal Humerus Plates (K082625) Biomet Proximal Humerus Plating System (K143697) Synthes Small Fragment DCL System (K000684) Stryker Plating System (K060514)…
Biomet Manufacturing201518
*K000684Small Fragment Dynamic Compression Locking (DCL) System
Summary page 4
…mal Humerus Plates (K082625) Biomet Proximal Humerus Plating System (K143697) Synthes Small Fragment DCL System (K000684) Stryker Plating System (K060514) PERI-LOC Plating and Screw System (K083032)…
Synthes (Usa)20001
*K060514Stryker Plating System
Summary page 4
…Biomet Proximal Humerus Plating System (K143697) Synthes Small Fragment DCL System (K000684) Stryker Plating System (K060514) PERI-LOC Plating and Screw System (K083032) Arthrex Fracture System (K112437)…
Howmedica Osteonics Corp.2006—
*K083032Peri-Loc Bone Plating and Screw System
Summary page 4
…97) Synthes Small Fragment DCL System (K000684) Stryker Plating System (K060514) PERI-LOC Plating and Screw System (K083032) Arthrex Fracture System (K112437) OrthoPediatrics PediLoc Locking Plate System (K083286)…
Smith & Nephew, Inc.20092
*K083286Orthopediatrics Pediloc Locking Plate System
Summary page 4
…PERI-LOC Plating and Screw System (K083032) Arthrex Fracture System (K112437) OrthoPediatrics PediLoc Locking Plate System (K083286) Synthes Modular Mini Fragment LCP (K063049) GPC BRAND Locking Bone Plates and Screws (K15371…
OrthoPediatrics Corp.20095
*K063049Synthes (Usa) Modular Mini Fragment LCP System
Summary page 4
…Arthrex Fracture System (K112437) OrthoPediatrics PediLoc Locking Plate System (K083286) Synthes Modular Mini Fragment LCP (K063049) GPC BRAND Locking Bone Plates and Screws (K153716) Synthes Large Fragment DCL System (K00068…
Synthes (Usa)20064
*K153716GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System.
Summary page 4
…diatrics PediLoc Locking Plate System (K083286) Synthes Modular Mini Fragment LCP (K063049) GPC BRAND Locking Bone Plates and Screws (K153716) Synthes Large Fragment DCL System (K000682) K163361 - Page 2 of…
Gpc Medical, Ltd.2016—
*K000682Synthes Large Fragment Dynamic Compression Locking (DCL) System
Summary page 4
…Synthes Modular Mini Fragment LCP (K063049) GPC BRAND Locking Bone Plates and Screws (K153716) Synthes Large Fragment DCL System (K000682) K163361 - Page 2 of 2 EVOS Mini-Fragment Plating System (K…
Synthes (Usa)2000—
*K140814Evos Mini-Fragment Plating System
Summary page 5
…ynthes Large Fragment DCL System (K000682) K163361 - Page 2 of 2 EVOS Mini-Fragment Plating System (K140814) TriMed Volar Buttress Pin (K951303) AFT GTF System (K133668) Modifie…
Smith & Nephew, Inc.20142
*K951303SFC
Summary page 5
…== K163361 - Page 2 of 2 EVOS Mini-Fragment Plating System (K140814) TriMed Volar Buttress Pin (K951303) AFT GTF System (K133668) Modified Shoulder Fixation System (K060290)…
Medpac1995—
*K133668Aft Greater Tuberosity Fracture Plate, Left, Aft Greater Tuberosity Fracture Plate…
Summary page 5
…ge 2 of 2 EVOS Mini-Fragment Plating System (K140814) TriMed Volar Buttress Pin (K951303) AFT GTF System (K133668) Modified Shoulder Fixation System (K060290) Synthes LCP Dia-Meta Volar Distal Radius Pla…
Shoulder Options, Inc.2014—
*K060290Shoulder Fixation System
Summary page 5
…tem (K140814) TriMed Volar Buttress Pin (K951303) AFT GTF System (K133668) Modified Shoulder Fixation System (K060290) Synthes LCP Dia-Meta Volar Distal Radius Plates (K070946) Purpose: The purpose of this submission is to req…
Hand Innovations, LLC2006—
*K070946Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius Plates
Summary page 5
…AFT GTF System (K133668) Modified Shoulder Fixation System (K060290) Synthes LCP Dia-Meta Volar Distal Radius Plates (K070946) Purpose: The purpose of this submission is to request clearance for the ANTHEM™ Fracture System. Device Description: The ANTHE…
Synthes (Usa)20071

Also cleared against K073460: 11 other devices →

What descends from it? (14)

See all 14

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K173166ANTHEM Fracture SystemGlobus Medical, Inc.201711
K180554ANTHEM Fracture SystemGlobus Medical, Inc.201810
K202496ANTHEM Fracture SystemGlobus Medical, Inc.20208
K173746Activmotion RangeNewclip Technics20181
K251161ANTHEM® Fracture SystemGlobus Medical, Inc.20250

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 21 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
  • 46 of the 229 ancestors have a recall of any class.
  • Of its descendants, K173166 (Globus Medical, Inc., 2017) has gone furthest, with 11 descendants of its own.
  • 11 other devices also cite its predicate K073460.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

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. Small fragment and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 years of age).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K073460

11 other devices cite the same predicate.

  • K230623KITE Distal Fibula KitIntrauma S.P.A · 2023
  • K223150APS Metal Plate & Screw SystemA Plus Biotechnology Co., Ltd. · 2023
  • K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation · 2022
  • K191793Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating SystemNebula Surgical Private Limited · 2019
  • K162674BioPro Foot Plating SystemsBiopro, Inc. · 2017
  • K163383GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic…Greens Surgicals Pvt., Ltd. · 2017

More from Globus Medical, Inc.

184 FDA decisions under this applicant name. See the company

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K254043TRIVANCE™ Hip StemGlobus Medical, Inc. · 2026
  • K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc. · 2026
  • K253739SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System…Globus Medical, Inc. · 2026
  • K253401SCRIPT™ Implant SystemGlobus Medical, Inc. · 2026

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K163361 · printed Nov 6, 2026

Cite this page

510(k) Report. “K163361: 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/K163361

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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