510(k) · Cleared
ClearedAlians Fragment Specific
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 Jun 16, 2017 as substantially equivalent to K142906 (Medartis AG, 2015) and 5 other predicates after an 87-day review. Its family tree reaches back 14 generations to 1996. 1 later device descends from it.
- Decided
- Jun 16, 2017
- Review
- 87 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 14 generations to K962616 (1996). 151 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 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 deviceK170843 Alians Fragment SpecificNewclip Technics · 2017
- Descendant · cites it directly · 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 deviceK170843 Alians Fragment SpecificNewclip Technics · 2017
Most influential descendants
Showing 1 of 1 · See all- K213214Xpert WristNewclip Technics · 2021 · cites it directly0descendants
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) | K170843 | Alians Fragment Specific | Newclip Technics | 2017 | — |
| +1 | K213214 | Xpert Wrist | Newclip Technics | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 11 | 0 |
| 2001 | 11 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 9 | 0 |
| 2005 | 9 | 0 |
| 2006 | 12 | 0 |
| 2007 | 6 | 0 |
| 2008 | 6 | 0 |
| 2009 | 10 | 0 |
| 2010 | 8 | 0 |
| 2011 | 6 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (6)
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 |
|---|---|---|---|
| * | K142906 | APTUS Wrist 2.5 SystemSummary page 5…K170843 Page 2 of 3 3. Primary predicate or legally marketed devices which are substantially equivalent: • APTUS® Wrist 2.5 System of Medartis (K142906) Secondary predicate or legally marketed devices which are substantially equivalent: • Trimed Bone Plates of Trimed (K060041)… | 2015 |
| * | K060041 | Trimed Bone PlatesSummary page 5…• APTUS® Wrist 2.5 System of Medartis (K142906) Secondary predicate or legally marketed devices which are substantially equivalent: • Trimed Bone Plates of Trimed (K060041) • 2.4mm VA-LCP Dorsal Distal Radius Plates of Synthes (K102694), • Universal Distal Radius System of Newclip Technics (K1307… | 2006 |
| * | K102694 | 2.4MM VA-LCP Dorsal Distal Radius PlatesSummary page 5…icate or legally marketed devices which are substantially equivalent: • Trimed Bone Plates of Trimed (K060041) • 2.4mm VA-LCP Dorsal Distal Radius Plates of Synthes (K102694), • Universal Distal Radius System of Newclip Technics (K130774). • Footmotion Plating System of Newclip (K161448) • Activ… | 2010 |
| * | K130774 | Universal Distal Radius SystemSummary page 5…nt: • Trimed Bone Plates of Trimed (K060041) • 2.4mm VA-LCP Dorsal Distal Radius Plates of Synthes (K102694), • Universal Distal Radius System of Newclip Technics (K130774). • Footmotion Plating System of Newclip (K161448) • Activ Ankle Locking Plating System of Newclip (K143061) 4. Description… | 2013 |
| * | K161448 | Footmotion Plating SystemSummary page 5….4mm VA-LCP Dorsal Distal Radius Plates of Synthes (K102694), • Universal Distal Radius System of Newclip Technics (K130774). • Footmotion Plating System of Newclip (K161448) • Activ Ankle Locking Plating System of Newclip (K143061) 4. Description of the device: The Alians Fragment Specific ran… | 2016 |
| * | K143061 | Activ Ankle Locking Plating SystemSummary page 5…, • Universal Distal Radius System of Newclip Technics (K130774). • Footmotion Plating System of Newclip (K161448) • Activ Ankle Locking Plating System of Newclip (K143061) 4. Description of the device: The Alians Fragment Specific range consists of plates and… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213214 | Xpert Wrist | 2021 | 0 |
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 6 companies; a new generation was cleared every 1.6 years on median.
- 38 of the 151 ancestors have a recall of any class.
- Of its descendants, K213214 (Newclip Technics, 2021) has gone furthest, with 0 descendants of its own.
- 15 other devices also cite its predicate K142906.
How does its category compare?
All HRS devicesHRS 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
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 Fragment Specific range is intended for hand and forearm fractures, osteotomies and arthrodeses 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/K170843 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170843: Alians Fragment Specific.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170843
Report an extraction error
Are you the manufacturer?
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