510(k) · Cleared
ClearedAND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Suzhou and Science & Technology Development Corp. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jun 18, 2026 as substantially equivalent to K172830 (Double Medical Technology, Inc., 2018) after a 268-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Jun 18, 2026
- Review
- 268 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K951740 (1995). 21 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK951740 Intramedulary Fixation RodAcu Med, Inc. · 1995 · Recalled
- 4 generations backK032722 Trigen Straight Humeral Nail SystemSmith & Nephew, Inc. · 2003
- 3 generations backK051557 Trigen Retrograde Femoral, Supracondylar and Tibial NailsSmith & Nephew, Inc. · 2005
- 2 generations backK070761 Sanatmetal Nails and PinsSanatmetal Mfr. of Orthopaedic/Traumatologic Prod. · 2008
- 1 generation backK172830 Double Medical Femoral Nail SystemDouble Medical Technology, Inc. · 2018
- This deviceK253080 AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail…Suzhou and Science & Technology Development Corp. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K951740 | Intramedulary Fixation Rod | Acu Med, Inc. | 1995 | 1 |
| −4 | K032722 | Trigen Straight Humeral Nail System | Smith & Nephew, Inc. | 2003 | — |
| −3 | K051557 | Trigen Retrograde Femoral, Supracondylar and Tibial Nails | Smith & Nephew, Inc. | 2005 | — |
| −2 | K070761 | Sanatmetal Nails and Pins | Sanatmetal Mfr. of Orthopaedic/Traumatologic Prod. | 2008 | — |
| −1 | K172830 | Double Medical Femoral Nail System | Double Medical Technology, Inc. | 2018 | — |
| 0 (this device) | K253080 | AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System… | Suzhou and Science & Technology Development Corp. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 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? (1)
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 |
|---|---|---|---|
| * | K172830 | Double Medical Femoral Nail SystemSummary page 5…3020 Product Code(s) HSB, HWC I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K172830 Double Medical Femoral Nail System HSB Device Description Summary 21 CFR 807.92(a)(4) AND Medical Femoral Nail System is made of… | 2018 |
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 31 years and passes through 5 companies; a new generation was cleared every 7.8 years on median.
- 9 of the 21 ancestors have a recall of any class.
- 1 other device also cites its predicate K172830.
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. 2026, this device’s year, is highlighted.
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?
AND Medical Femoral Nail System is Suitable for intramedullary fixation of femoral fractures.
Indications for use of the PFNAO2(Length 170 mm - 240 mm) include:
— Pertrochanteric fractures;
— Intertrochanteric fractures;
— High subtrochanteric fractures.
Indications for use of the PFNAO1 (Length 320 mm - 420 mm), include:
— Low and extended subtrochanteric fractures;
— |Ipsilateral trochanteric fractures;
— Combination fractures (in the proximal femur);
— Pathological fractures.
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/K253080 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253080: AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253080
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026