510(k) · Cleared
ClearedAlians Elbow Locking Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Newclip Technics · HRS Plate, Fixation, Bone
Cleared on Aug 17, 2016 as substantially equivalent to K120070 (Synthes USA, 2012) and 6 other predicates after a 370-day review. Its family tree reaches back 14 generations to 1996. 6 later devices descend from it.
- Decided
- Aug 17, 2016
- Review
- 370 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 14 generations to K962616 (1996). 103 ancestors in all, the oldest K792022 (1979). 6 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- 2 generations backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- 1 generation backK143061 Activ Ankle Locking Plating SystemNewclip Technics · 2015
- This deviceK152289 Alians Elbow Locking Plating SystemNewclip Technics · 2016
- Descendant · cites it directly · 3 of its ownK173641 Activ AnkleNewclip Technics · 2018
- Descendant · 2 generations on · 0 of its ownK261511 Xpert AnkleNewclip Technics · 2026
- Descendant · cites it directly · 0 of its ownK261191 Alians Elbow SNewclip Technics · 2026
- Descendant · 2 generations on · 0 of its ownK221395 Footmotion Plating SystemNewclip Technics · 2022
- Descendant · 2 generations on · 0 of its ownK213214 Xpert WristNewclip Technics · 2021
Show all 14 generations
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 12 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 11 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 8 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 7 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 6 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 5 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 4 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 3 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- 2 generations backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- 1 generation backK143061 Activ Ankle Locking Plating SystemNewclip Technics · 2015
- This deviceK152289 Alians Elbow Locking Plating SystemNewclip Technics · 2016
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K173641Activ AnkleNewclip Technics · 2018 · cites it directly3descendants
- K261511Xpert AnkleNewclip Technics · 2026 · 2 generations on0descendants
- K261191Alians Elbow SNewclip Technics · 2026 · cites it directly0descendants
- K221395Footmotion Plating SystemNewclip Technics · 2022 · 2 generations on0descendants
- K213214Xpert WristNewclip Technics · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −13 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −12 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −11 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −8 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −7 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −6 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −5 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −4 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
| −3 | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal… | Synthes USA | 2012 | — |
| −2 | K120854 | Synthes VA LCP Ankle Trauma System | Synthes USA | 2012 | — |
| −1 | K143061 | Activ Ankle Locking Plating System | Newclip Technics | 2015 | — |
| 0 (this device) | K152289 | Alians Elbow Locking Plating System | Newclip Technics | 2016 | — |
| +1 | K173641 | Activ Ankle | Newclip Technics | 2018 | — |
| +2 | K261511 | Xpert Ankle | Newclip Technics | 2026 | — |
| +1 | K261191 | Alians Elbow S | Newclip Technics | 2026 | — |
| +2 | K221395 | Footmotion Plating System | Newclip Technics | 2022 | — |
| +2 | K213214 | Xpert Wrist | Newclip Technics | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 9 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 5 | 0 |
| 2006 | 7 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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? (7)
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 |
|---|---|---|---|
| * | K120070 | Synthes Variable Angle LCP Elbow SystemSummary page 4…ich are substantially equivalent: The Synthes Variable Angle LCP Elbow System (medial and posterolateral distal humerus plates) of Synthes (K120070 and K120717) K152289 Pg.2/3 Secondary predicate… | 2012 |
| * | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Summary page 4…tantially equivalent: The Synthes Variable Angle LCP Elbow System (medial and posterolateral distal humerus plates) of Synthes (K120070 and K120717) K152289 Pg.2/3 Secondary predicate or legally… | 2012 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 5…2/3 Secondary predicate or legally marketed devices which are substantially equivalent: The Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684) The Synthes One Third DCL Plate (same as DePuy) (K011335) The Epi-union Plating System of Stryker (K974289) The TC-1… | 2000 |
| * | K011335 | Synths One-Third Tubular DCL PlateSummary page 5…are substantially equivalent: The Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684) The Synthes One Third DCL Plate (same as DePuy) (K011335) The Epi-union Plating System of Stryker (K974289) The TC-100 Screw & Plating System (K993106) The Activ Ankle Lockin… | 2001 |
| * | K974289 | Epi-Union Plating SystemSummary page 5…ragment Dynamic Compression Locking (DCL) System (K000684) The Synthes One Third DCL Plate (same as DePuy) (K011335) The Epi-union Plating System of Stryker (K974289) The TC-100 Screw & Plating System (K993106) The Activ Ankle Locking Plating system of Newclip Technics (K143061) 4. De… | 1998 |
| * | K993106 | Smith & Nephew Bone Plate System (Bone Plates, Bone Screws and Accessories)Summary page 5…stem (K000684) The Synthes One Third DCL Plate (same as DePuy) (K011335) The Epi-union Plating System of Stryker (K974289) The TC-100 Screw & Plating System (K993106) The Activ Ankle Locking Plating system of Newclip Technics (K143061) 4. Description of the The Alians Elbow Locking Pla… | 1999 |
| * | K143061 | Activ Ankle Locking Plating SystemSummary page 5…35) The Epi-union Plating System of Stryker (K974289) The TC-100 Screw & Plating System (K993106) The Activ Ankle Locking Plating system of Newclip Technics (K143061) 4. Description of the The Alians Elbow Locking Plating system consists of device: plates and screws, desig… | 2015 |
What descends from it? (6)
3 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 20 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 23 of the 103 ancestors have a recall of any class.
- Of its descendants, K173641 (Newclip Technics, 2018) has gone furthest, with 3 descendants of its own.
- 14 other devices also cite its predicate K120070.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Alians Elbow Locking Plating System is intended for the fixation of fractures and osteotomies of the distal humerus and
proximal ulna in adults.
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/K152289 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152289: Alians Elbow Locking Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152289
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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