510(k) · Cleared
ClearedXLO Brand of Locking Distal Humerus Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho Life Systems Private Limited · HRS Plate, Fixation, Bone
Cleared on Apr 26, 2024 as substantially equivalent to K120717 (Synthes USA, 2012) and 3 other predicates after a 141-day review. Its family tree reaches back 12 generations to 1996.
- Decided
- Apr 26, 2024
- Review
- 141 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 12 generations to K962616 (1996). 88 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 2 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 1 generation backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- This deviceK233873 XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited · 2024
Show all 12 generations
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 2 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 1 generation backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- This deviceK233873 XLO Brand of Locking Distal Humerus Plating SystemOrtho Life Systems Private Limited · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −11 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −10 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −9 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −6 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −5 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −4 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −3 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −2 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
| −1 | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal… | Synthes USA | 2012 | — |
| 0 (this device) | K233873 | XLO Brand of Locking Distal Humerus Plating System | Ortho Life Systems Private Limited | 2024 | — |
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 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 9 | 0 |
| 2001 | 9 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 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? (4)
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 |
|---|---|---|---|
| * | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Summary page 5…Following are the predicate device 510(k) with which we are claiming substantial equivalence: Primary Predicate Device: • Synthes Variable Angle LCP Elbow System (K120717) Additional Predicate Devices: • Synthes 3.5mm LCP Distal Humerus System (K033995) Synthes Small Fragment Dynamic… | 2012 |
| * | K033995 | 3.5 MM LCP Distal Humerus SystemSummary page 5…nce: Primary Predicate Device: • Synthes Variable Angle LCP Elbow System (K120717) Additional Predicate Devices: • Synthes 3.5mm LCP Distal Humerus System (K033995) Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684) Synthes Cortical Screws (K112583) (a.… | 2004 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 5…120717) Additional Predicate Devices: • Synthes 3.5mm LCP Distal Humerus System (K033995) Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684) Synthes Cortical Screws (K112583) (a.4). A description of the device that is the subject of the premarket notification… | 2000 |
| * | K112583 | Synthes Cortical ScrewsSummary page 5…• Synthes 3.5mm LCP Distal Humerus System (K033995) Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684) Synthes Cortical Screws (K112583) (a.4). A description of the device that is the subject of the premarket notification submission, such as might be found in the l… | 2011 |
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 28 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 19 of the 88 ancestors have a recall of any class.
- 7 other devices also cite its predicate K120717.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 XLO Brand of Locking Distal Humerus Plating System is indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.
The system is indicated for use in adult patients only. All implants are for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233873 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233873: XLO Brand of Locking Distal Humerus 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/K233873
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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