510(k) Report

510(k) · Cleared

Cleared

Xpert Wrist

K213214510(k) TraditionalCleared Nov 24, 202156-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

Newclip Technics · HRS Plate, Fixation, Bone

Cleared on Nov 24, 2021 as substantially equivalent to K170843 (Newclip Technics, 2017) and 11 other predicates after a 56-day review. Its family tree reaches back 16 generations to 1996.

Decided
Nov 24, 2021
Review
56 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
12

Its longest line of descent runs back 16 generations to K962616 (1996). 185 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2018: 1 other ancestor2017: 3 other ancestors2015: 3 other ancestors2014: 1 other ancestor2013: 3 other ancestors2006: 15 other ancestors2005: 11 other ancestors2004: 12 other ancestors2016: 2 other ancestors2012: 3 other ancestors2011: 7 other ancestors2010: 8 other ancestors2008: 9 other ancestors2007: 7 other ancestors2003: 7 other ancestors2000: 12 other ancestors1996: 10 other ancestors2009: 10 other ancestors2002: 4 other ancestors2001: 12 other ancestors1999: 5 other ancestors1998: 5 other ancestors1995: 2 other ancestors1991: 1 other ancestor1989: 2 other ancestors1997: 3 other ancestors1992: 1 other ancestor1990: 3 other ancestors1994: 4 other ancestors1993: 2 other ancestors1979: 1 other ancestorK962616 · Synthes Dorsal Distal Radius Plate (DDRP) System · Synthes (Usa) · 1996K982732 · Synthes (Usa) Distal Radius Plate System (DRPS) · Synthes · 1998×2: 2 generations cleared close together, K023007 (2002), K030198 (2003) K032705 · Distal Radius Fracture Repair System · Hand Innovations, Inc. · 2003×2: 2 generations cleared close together, K050932 (2005), K051735 (2005) K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K100776 · Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System · Synthes (Usa) · 2010×3: 3 generations cleared close together, K120070 (2012), K120717 (2012), K120854 (2012) K143061 · Activ Ankle Locking Plating System · Newclip Technics · 2015K152289 · Alians Elbow Locking Plating System · Newclip Technics · 2016K173641 · Activ Ankle · Newclip Technics · 201819801990200020102020
Other ancestors, by generation 1 generation back: 10 other ancestors2 generations back: 20 other ancestors3 generations back: 39 other ancestors4 generations back: 34 other ancestors5 generations back: 25 other ancestors6 generations back: 15 other ancestors7 generations back: 10 other ancestors8 generations back: 7 other ancestors9 generations back: 8 other ancestors10 generations back: 1 other ancestor K173641 · Activ Ankle · Newclip Technics · 2018K152289 · Alians Elbow Locking Plating System · Newclip Technics · 2016K143061 · Activ Ankle Locking Plating System · Newclip Technics · 2015K120854 · Synthes VA LCP Ankle Trauma System · Synthes USA · 2012K120717 · Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates) · Synthes USA · 2012K120070 · Synthes Variable Angle LCP Elbow System · Synthes USA · 2012 · recalledK100776 · Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System · Synthes (Usa) · 2010K090675 · Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories · Smith & Nephew, Inc. · 2009K071563 · Peri-Loc Periarticular Locked Plating System · Smith & Nephew, Inc. · 2007K051735 · 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) · 1996−15−10−50
  1. Root · 16 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 12 generations between
  3. 3 generations backK143061 Activ Ankle Locking Plating SystemNewclip Technics · 2015
  4. 2 generations backK152289 Alians Elbow Locking Plating SystemNewclip Technics · 2016
  5. 1 generation backK173641 Activ AnkleNewclip Technics · 2018
  6. This deviceK213214 Xpert WristNewclip Technics · 2021
Show all 16 generations
  1. Root · 16 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
  2. 15 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
  3. 14 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
  4. 13 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  5. 12 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
  6. 11 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
  7. 10 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
  8. 9 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
  9. 8 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
  10. 7 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
  11. 6 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
  12. 5 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
  13. 4 generations backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
  14. 3 generations backK143061 Activ Ankle Locking Plating SystemNewclip Technics · 2015
  15. 2 generations backK152289 Alians Elbow Locking Plating SystemNewclip Technics · 2016
  16. 1 generation backK173641 Activ AnkleNewclip Technics · 2018
  17. This deviceK213214 Xpert WristNewclip Technics · 2021
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K962616Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa)1996—
−15K982732Synthes (Usa) Distal Radius Plate System (DRPS)Synthes1998—
−14K023007Distal Radius Fracture Repair SystemHand Innovations, Inc.2002—
−13K030198Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−12K032705Distal Radius Fracture Repair SystemHand Innovations, Inc.2003—
−11K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc.20051
−10K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc.2005—
−9K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc.2007—
−8K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc.2009—
−7K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa)2010—
−6K120070Synthes Variable Angle LCP Elbow SystemSynthes USA20121
−5K120717Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal…Synthes USA2012—
−4K120854Synthes VA LCP Ankle Trauma SystemSynthes USA2012—
−3K143061Activ Ankle Locking Plating SystemNewclip Technics2015—
−2K152289Alians Elbow Locking Plating SystemNewclip Technics2016—
−1K173641Activ AnkleNewclip Technics2018—
0 (this device)K213214Xpert WristNewclip Technics2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197910
198920
199030
199110
199210
199320
199440
199520
1996100
199730
199850
199950
2000120
2001120
200240
200370
2004120
2005110
2006150
200770
200890
2009100
201080
201170
201230
201330
201410
201530
201620
201730
201810
FIG. 1 — Lineage of K213214, 1996–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K170843Alians Fragment Specific
Summary page 5
…K213214 3. Primary predicate or legally marketed devices which are substantially equivalent: x Alians Fragment Specific of Newclip Technics (K170843) Additional predicate or legally marketed devices which are substantially equivalent: x Trimed Bone Plates of Trimed (K06004…
Newclip Technics2017—
*K060041Trimed Bone Plates
Summary page 5
…Fragment Specific of Newclip Technics (K170843) Additional predicate or legally marketed devices which are substantially equivalent: x Trimed Bone Plates of Trimed (K060041), x Synthes (USA) LCP Wrist Fusion Plates of Synthes (K042355), x APTUS® Wrist 2.5 System of Medartis (K142906 and K172170)…
TriMed, Inc.20063
*K042355Synthes (Usa) LCP Wrist Fusion Plates
Summary page 5
…icate or legally marketed devices which are substantially equivalent: x Trimed Bone Plates of Trimed (K060041), x Synthes (USA) LCP Wrist Fusion Plates of Synthes (K042355), x APTUS® Wrist 2.5 System of Medartis (K142906 and K172170), x APTUS Titanium Fixation System of Medartis (K051567), x…
Synthes (Usa)2004—
*K142906APTUS Wrist 2.5 System
Summary page 5
…ially equivalent: x Trimed Bone Plates of Trimed (K060041), x Synthes (USA) LCP Wrist Fusion Plates of Synthes (K042355), x APTUS® Wrist 2.5 System of Medartis (K142906 and K172170), x APTUS Titanium Fixation System of Medartis (K051567), x Skeletal Dynamics Protean Fragment Plate System (K1…
Medartis AG2015—
*K172170APTUS (R) Wrist 2.5 System
Summary page 5
…lent: x Trimed Bone Plates of Trimed (K060041), x Synthes (USA) LCP Wrist Fusion Plates of Synthes (K042355), x APTUS® Wrist 2.5 System of Medartis (K142906 and K172170), x APTUS Titanium Fixation System of Medartis (K051567), x Skeletal Dynamics Protean Fragment Plate System (K140372), x…
Medartis AG2017—
*K051567Aptus Titanium Osteosynthesis System
Summary page 5
…thes (USA) LCP Wrist Fusion Plates of Synthes (K042355), x APTUS® Wrist 2.5 System of Medartis (K142906 and K172170), x APTUS Titanium Fixation System of Medartis (K051567), x Skeletal Dynamics Protean Fragment Plate System (K140372), x Geminus Volar Distal Radius Plate System (K182492), x A…
Medartis, Inc.20051
*K140372Fragment Plate System
Summary page 5
…TUS® Wrist 2.5 System of Medartis (K142906 and K172170), x APTUS Titanium Fixation System of Medartis (K051567), x Skeletal Dynamics Protean Fragment Plate System (K140372), x Geminus Volar Distal Radius Plate System (K182492), x Acumed Wrist Spanning Plate (K131764), x Activ Ankle of Newcli…
Skeletal Dynamics, LLC2014—
*K182492Geminus Volar Distal Radius Plate System
Summary page 5
…x APTUS Titanium Fixation System of Medartis (K051567), x Skeletal Dynamics Protean Fragment Plate System (K140372), x Geminus Volar Distal Radius Plate System (K182492), x Acumed Wrist Spanning Plate (K131764), x Activ Ankle of Newclip Technics (K143061 and K173641), x High Tibial Osteot…
Skeletal Dynamics, LLC2018—
*K131764Acumed Wrist Spanning Plate
Summary page 5
…tis (K051567), x Skeletal Dynamics Protean Fragment Plate System (K140372), x Geminus Volar Distal Radius Plate System (K182492), x Acumed Wrist Spanning Plate (K131764), x Activ Ankle of Newclip Technics (K143061 and K173641), x High Tibial Osteotomy System of Newclip Technics (K141548) 4…
Acumed, LLC2013—
*K143061Activ Ankle Locking Plating System
Summary page 5
…agment Plate System (K140372), x Geminus Volar Distal Radius Plate System (K182492), x Acumed Wrist Spanning Plate (K131764), x Activ Ankle of Newclip Technics (K143061 and K173641), x High Tibial Osteotomy System of Newclip Technics (K141548) 4. Description of the device: The Xpert Wrist r…
Newclip Technics2015—
*K173641Activ Ankle
Summary page 5
…System (K140372), x Geminus Volar Distal Radius Plate System (K182492), x Acumed Wrist Spanning Plate (K131764), x Activ Ankle of Newclip Technics (K143061 and K173641), x High Tibial Osteotomy System of Newclip Technics (K141548) 4. Description of the device: The Xpert Wrist range consist…
Newclip Technics2018—
*K141548High Tibial Osteotomy System
Summary page 5
…(K182492), x Acumed Wrist Spanning Plate (K131764), x Activ Ankle of Newclip Technics (K143061 and K173641), x High Tibial Osteotomy System of Newclip Technics (K141548) 4. Description of the device: The Xpert Wrist range consists of plates and screws, designed…
Newclip Technics2015—

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 25 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
  • 45 of the 185 ancestors have a recall of any class.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 implants of the Xpert Wrist range are intended for the fixation of hand and forearm fractures, osteotomies and arthrodeses in adults.

Indications for use as stated in the FDA summary.

More from Newclip Technics

35 FDA decisions under this applicant name. See the company

  • K262649Alians ForearmNewclip Technics · 2026
  • K261511Xpert AnkleNewclip Technics · 2026
  • K261191Alians Elbow SNewclip Technics · 2026
  • K261038Xpert PFPNewclip Technics · 2026
  • K253906Xpert HandNewclip Technics · 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/K213214 · printed Nov 6, 2026

Cite this page

510(k) Report. “K213214: Xpert Wrist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213214

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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