510(k) · Cleared
Recalled · Class II · 20192.4MM VA-LCP Intercarpal Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HRS Plate, Fixation, Bone
Cleared on Jan 21, 2011 as substantially equivalent to K990094 (Kinetikos Medical, Inc., 1999) and 2 other predicates after an 81-day review. Its family tree reaches back 4 generations to 1992. 18 later devices descend from it. It has been recalled 7 times.
- Decided
- Jan 21, 2011
- Review
- 81 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 7
- Predicates
- 3
Its longest line of descent runs back 4 generations to K915818 (1992). 13 ancestors in all, the oldest K800806 (1980). 18 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992 · Recalled
- 3 generations backK990094 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- 2 generations backK991873 Kmi Wrist Fusion SystemKinetikos Medical, Inc. · 1999
- 1 generation backK021321 Wrist Fusion PlateAcu Med, Inc. · 2002
- This deviceK103243 2.4MM VA-LCP Intercarpal Fusion SystemSynthes (Usa) · 2011
- Descendant · cites it directly · 14 of its ownK123562 Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation · 2013 · Recalled
- Descendant · 2 generations on · 11 of its ownK131657 Flower Small and Medium Implant SetFlower Orthopedics Corporation · 2013 · Recalled
- Descendant · 2 generations on · 7 of its ownK152306 MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC · 2015
- Descendant · 3 generations on · 6 of its ownK160300 MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC · 2016
- Descendant · 3 generations on · 4 of its ownK173710 MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC · 2018 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation · 2013 · cites it directly14descendants
- K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation · 2013 · 2 generations on11descendants
- K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC · 2015 · 2 generations on7descendants
- K160300MotoBand (TM) CP Implant SystemCrossroads Extremity Systems, LLC · 2016 · 3 generations on6descendants
- K173710MotoBAND CP Implant SystemCrossroads Extremity Systems, LLC · 2018 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915818 | Synthes (R) Titanium Small Reconstruction Plate | Synthes (Usa) | 1992 | 2 |
| −3 | K990094 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| −2 | K991873 | Kmi Wrist Fusion System | Kinetikos Medical, Inc. | 1999 | — |
| −1 | K021321 | Wrist Fusion Plate | Acu Med, Inc. | 2002 | — |
| 0 (this device) | K103243 | 2.4MM VA-LCP Intercarpal Fusion System | Synthes (Usa) | 2011 | — |
| +1 | K123562 | Flower Small and Medium Bone Implants | Flower Orthopedics Corporation | 2013 | 2 |
| +2 | K131657 | Flower Small and Medium Implant Set | Flower Orthopedics Corporation | 2013 | 1 |
| +2 | K152306 | MotoBand¿ CP Implant System | Crossroads Extremity Systems, LLC | 2015 | — |
| +3 | K160300 | MotoBand (TM) CP Implant System | Crossroads Extremity Systems, LLC | 2016 | — |
| +3 | K173710 | MotoBAND CP Implant System | Crossroads Extremity Systems, LLC | 2018 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K990094 | Kmi Wrist Fusion SystemSummary page 1…Class 11, §888.3040 - Smooth or threaded metallic bone fixation fastener, HWC Predicate Device: KM I - Wrist Fusion System (K990094) KM I - Wrist Fusion System (K991873) Acumned - Hub Cap Limited Wrist… | 1999 |
| * | K991873 | Kmi Wrist Fusion SystemSummary page 1…fastener, HWC Predicate Device: KM I - Wrist Fusion System (K990094) KM I - Wrist Fusion System (K991873) Acumned - Hub Cap Limited Wrist Fusion Plate (K021321) Device Description: The 2.4mm VA… | 1999 |
| * | K021321 | Wrist Fusion PlateSummary page 1…st Fusion System (K990094) KM I - Wrist Fusion System (K991873) Acumned - Hub Cap Limited Wrist Fusion Plate (K021321) Device Description: The 2.4mm VA-LCP Intercarpal Fusion System features low profile cir… | 2002 |
What descends from it? (18)
See all 183 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 16, 2019 | Class II | Z-0879-2020 | Under Investigation by firm | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay.… |
| Dec 16, 2019 | Class II | Z-0882-2020 | Under Investigation by firm | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay.… |
| Dec 16, 2019 | Class II | Z-0883-2020 | Under Investigation by firm | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay.… |
| Dec 16, 2019 | Class II | Z-0880-2020 | Under Investigation by firm | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay.… |
| Dec 16, 2019 | Class II | Z-0881-2020 | Under Investigation by firm | There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube. In both instances this could prevent the screw from being removed and used causing a surgical delay.… |
| Jun 28, 2016 | Class II | Z-2389-2016 | Nonconforming Material/Component | It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being too close to the StarDrive feature… |
| Nov 2, 2015 | Class II | Z-0323-2016 | Process control | It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K123562 (Flower Orthopedics Corporation, 2013) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K990094.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 2.4mm VA-LCP Intercarpal Fusion System is indicated for fusion of small bones of the hand including: hamate, capitate, lunate, and triquetrum, for the revision of failed partial wrist fusions, and is indicated for use in patients suffering pain and/or loss of function due to:
-Osteoarthritis
-Rheumatoid arthritis
-Post-traumatic or degenerative wrist arthritis
-Carpal instability
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103243 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103243: 2.4MM VA-LCP Intercarpal Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103243
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