510(k) · Cleared
ClearedIP-XS Compression Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plus Orthopedics · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Sep 10, 2003 as substantially equivalent to K031438 (Acumed, LLC, 2003) after a 23-day review. Its family tree reaches back 2 generations to 1992. 5 later devices descend from it.
- Decided
- Sep 10, 2003
- Review
- 23 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913949 (1992). 4 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK913949 True/Flex Humerus, Ulna & Radius Intramed Rods SysApplied Osteo Systems, Inc. · 1992
- 1 generation backK031438 Acumed Small Bone Locking Rod System IIAcumed, LLC · 2003 · Recalled
- This deviceK032548 IP-XS Compression Nail SystemPlus Orthopedics · 2003
- Descendant · cites it directly · 2 of its ownK081356 Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC · 2008
- Descendant · 2 generations on · 1 of its ownK090091 Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC · 2009
- Descendant · cites it directly · 0 of its ownK161371 Sonoma Fifth Metatarsal Repair SystemSonoma Orthopedic Products, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK122170 Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc. · 2012 · Recalled
- Descendant · 3 generations on · 0 of its ownK110322 Olecra Intramedullary Fixation SystemMylad Orthopedic Solutions · 2011
Most influential descendants
Showing 5 of 5 · See all- K081356Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC · 2008 · cites it directly2descendants
- K090091Olecranail Intramedullary Fixation SystemMylad Orthopedic Solutions, LLC · 2009 · 2 generations on1descendant
- K161371Sonoma Fifth Metatarsal Repair SystemSonoma Orthopedic Products, Inc. · 2017 · cites it directly0descendants
- K122170Smith & Nephew, Inc. Intramedullary Nail System InstrumentationSmith & Nephew, Inc. · 2012 · cites it directly0descendants
- K110322Olecra Intramedullary Fixation SystemMylad Orthopedic Solutions · 2011 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913949 | True/Flex Humerus, Ulna & Radius Intramed Rods Sys | Applied Osteo Systems, Inc. | 1992 | — |
| −1 | K031438 | Acumed Small Bone Locking Rod System II | Acumed, LLC | 2003 | 1 |
| 0 (this device) | K032548 | IP-XS Compression Nail System | Plus Orthopedics | 2003 | — |
| +1 | K081356 | Olecranail Intramedullary Fixation System | Mylad Orthopedic Solutions, LLC | 2008 | — |
| +2 | K090091 | Olecranail Intramedullary Fixation System | Mylad Orthopedic Solutions, LLC | 2009 | — |
| +1 | K161371 | Sonoma Fifth Metatarsal Repair System | Sonoma Orthopedic Products, Inc. | 2017 | — |
| +1 | K122170 | Smith & Nephew, Inc. Intramedullary Nail System Instrumentation | Smith & Nephew, Inc. | 2012 | 1 |
| +3 | K110322 | Olecra Intramedullary Fixation System | Mylad Orthopedic Solutions | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 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 HSB? 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 HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K031438 | Acumed Small Bone Locking Rod System II | 2003 |
| * | — | SST Small Bone Locking Nail Named without a submission number |
What descends from it? (5)
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 11 years and passes through 3 companies; a new generation was cleared every 11.5 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K081356 (Mylad Orthopedic Solutions, LLC, 2008) has gone furthest, with 2 descendants of its own.
- 8 other devices also cite its predicate K031438.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, 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 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
The IP-XS Compression Nail System is inserted into the medullary canal of long bones for the alignment, stabilization and fixation of fractures caused by disease or trauma; the fixation of long bones that have been surgically prepared (osteotomy) for correction of defonnitr, and for arthordesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032548: IP-XS Compression Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032548
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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