510(k) Report

510(k) · Cleared

Cleared

Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525

K993074510(k) TraditionalCleared Dec 10, 199987-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bionx Implants, Ltd. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Dec 10, 1999 as substantially equivalent to K890902 (Davis & Geck, Inc., 1989) and 4 other predicates after an 87-day review. Its family tree reaches back 1 generation to 1987. 7 later devices descend from it.

Decided
Dec 10, 1999
Review
87 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K864912 (1987). 5 ancestors in all. 7 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 1 other ancestor1994: 1 other ancestor1990: 1 other ancestor1989: 1 other ancestor2007: 2 descendants cleared2001: 2 descendants cleared2003: 1 descendant cleared2004: 1 descendant cleared2008: 1 descendant clearedK864912 · PDS (Polydioxanon) Absorbable Pin · Johnson & Johnson Professionals, Inc. · 19871990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 5 descendants2 generations forward: 2 descendants K864912 · PDS (Polydioxanon) Absorbable Pin · Johnson & Johnson Professionals, Inc. · 19870
  1. Root · 1 generation backK864912 PDS (Polydioxanon) Absorbable PinJohnson & Johnson Professionals, Inc. · 1987
  2. This deviceK993074 Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525Bionx Implants, Ltd. · 1999
  3. Descendant · cites it directly · 5 of its ownK012000 1.5MM Bone Fixation KitBionx Implants, Ltd. · 2001
  4. Descendant · cites it directly · 4 of its ownK013546 Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214Bionx Implants, Inc. · 2001
  5. Descendant · cites it directly · 3 of its ownK031981 2.4 Smartnail, Models 532416, 532425, 532435, 532445Linvatec Biomaterials, Ltd. · 2003
  6. Descendant · cites it directly · 2 of its ownK041288 Modification to SmartpinLinvatec Biomaterials, Inc. · 2004
  7. Descendant · 2 generations on · 0 of its ownK073311 Osteotrans-OT PinTakiron Co., Ltd. · 2008

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2001: 22003: 12004: 12007: 22008: 1
2001high 2 (2001) · low 0 (2002)2026

Most influential descendants

Showing 5 of 7 · See all
  • K0120001.5MM Bone Fixation KitBionx Implants, Ltd. · 2001 · cites it directly5descendants
  • K013546Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214Bionx Implants, Inc. · 2001 · cites it directly4descendants
  • K0319812.4 Smartnail, Models 532416, 532425, 532435, 532445Linvatec Biomaterials, Ltd. · 2003 · cites it directly3descendants
  • K041288Modification to SmartpinLinvatec Biomaterials, Inc. · 2004 · cites it directly2descendants
  • K073311Osteotrans-OT PinTakiron Co., Ltd. · 2008 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K864912PDS (Polydioxanon) Absorbable PinJohnson & Johnson Professionals, Inc.1987—
0 (this device)K993074Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525Bionx Implants, Ltd.1999—
+1K0120001.5MM Bone Fixation KitBionx Implants, Ltd.2001—
+1K013546Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214Bionx Implants, Inc.2001—
+1K0319812.4 Smartnail, Models 532416, 532425, 532435, 532445Linvatec Biomaterials, Ltd.2003—
+1K041288Modification to SmartpinLinvatec Biomaterials, Inc.2004—
+2K073311Osteotrans-OT PinTakiron Co., Ltd.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198910
199010
199410
199710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200120
200310
200410
200720
200810
FIG. 1 — Lineage of K993074, 1987–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 MAI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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Get a 510(k) 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

TypeNumberDeviceApplicantDecidedRecalls
*K890902Biofix* Biodegradable Fixation Rod
Summary page 1
…n Name: Absorbable Bone Fixation Nail Classification Name: Bone Fixation Nail Device Product Code: JDS Predicate Devices: N — Bionx Implants, Inc. Biofix® SR-PGA Pin (K890902) Bionx Implants Inc. SmartPin™ (K925098) Johnson & Johnson Orthopedics, Inc. Orthosorb Absorbable Pin (K864912, K882979, K90145…
Davis & Geck, Inc.1989—
*K925098Biofix Absorbable Self-Reinforced Poly-L-Lactide
Summary page 1
…ssification Name: Bone Fixation Nail Device Product Code: JDS Predicate Devices: N — Bionx Implants, Inc. Biofix® SR-PGA Pin (K890902) Bionx Implants Inc. SmartPin™ (K925098) Johnson & Johnson Orthopedics, Inc. Orthosorb Absorbable Pin (K864912, K882979, K901456) Synthes Inc. Polypin (K961608) JofZ…
Bioscience, Inc.1994—
*K864912PDS (Polydioxanon) Absorbable Pin
Summary page 1
…Devices: N — Bionx Implants, Inc. Biofix® SR-PGA Pin (K890902) Bionx Implants Inc. SmartPin™ (K925098) Johnson & Johnson Orthopedics, Inc. Orthosorb Absorbable Pin (K864912, K882979, K901456) Synthes Inc. Polypin (K961608) JofZ Intended Use: Properly used, in the presence of adequat…
Johnson & Johnson Professionals, Inc.1987—
Kept off the family treeK882979Orthosorb Absorbable Pin
Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree
Summary page 1
…N — Bionx Implants, Inc. Biofix® SR-PGA Pin (K890902) Bionx Implants Inc. SmartPin™ (K925098) Johnson & Johnson Orthopedics, Inc. Orthosorb Absorbable Pin (K864912, K882979, K901456) Synthes Inc. Polypin (K961608) JofZ Intended Use: Properly used, in the presence of adequate immobil…
*K901456Orthosorb (R) Absorbable Pin
Summary page 1
…onx Implants, Inc. Biofix® SR-PGA Pin (K890902) Bionx Implants Inc. SmartPin™ (K925098) Johnson & Johnson Orthopedics, Inc. Orthosorb Absorbable Pin (K864912, K882979, K901456) Synthes Inc. Polypin (K961608) JofZ Intended Use: Properly used, in the presence of adequate immobilization,…
Johnson & Johnson International1990—
*K961608Synthes (U.S.a.) Polypin
Summary page 1
…A Pin (K890902) Bionx Implants Inc. SmartPin™ (K925098) Johnson & Johnson Orthopedics, Inc. Orthosorb Absorbable Pin (K864912, K882979, K901456) Synthes Inc. Polypin (K961608) JofZ Intended Use: Properly used, in the presence of adequate immobilization, absorbable SmartNail™ is intende…
Synthes (Usa)1997—

Also cleared against K890902: 2 other devices →

What descends from it? (7)

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K0120001.5MM Bone Fixation KitBionx Implants, Ltd.20015
K013546Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214Bionx Implants, Inc.20014
K0319812.4 Smartnail, Models 532416, 532425, 532435, 532445Linvatec Biomaterials, Ltd.20033
K041288Modification to SmartpinLinvatec Biomaterials, Inc.20042
K070178Aesculap Resorbable Pin, Model FR735Aesculap Implant System, Inc.20070

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?

  • None of the 5 ancestors has a recall.
  • Of its descendants, K012000 (Bionx Implants, Ltd., 2001) has gone furthest, with 5 descendants of its own.
  • 2 other devices also cite its predicate K890902.

How does its category compare?

All MAI devices

MAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MAI

8in 2025

2007: 42008: 32009: 92010: 42011: 92012: 62013: 62014: 42015: 52016: 32017: 92018: 132019: 92020: 92021: 82022: 62023: 82024: 72025: 82026 (partial year): 5
2007high 13 (2018) · low 3 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAI

54in 2025

2007: 100 days median2008: 83 days median2009: 74 days median2010: 122 days median2011: 90 days median2012: 56 days median2013: 135 days median2014: 86 days median2015: 95 days median2016: 191 days median2017: 113 days median2018: 108 days median2019: 41 days median2020: 78 days median2021: 115 days median2022: 136 days median2023: 34 days median2024: 53 days median2025: 54 days median2026 (partial year): 69 days median
2007high 191 (2016) · low 34 (2023)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAI

40in 2020

2011: 52012: 102019: 22020: 402026 (partial year): 1
2007high 40 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MAI

2,148in 2025

2007: 2722008: 1722009: 882010: 892011: 1292012: 1712013: 1662014: 1492015: 1822016: 3012017: 4782018: 1,5902019: 1,2482020: 9572021: 1,2672022: 1,4252023: 1,7182024: 2,3002025: 2,148
2007high 2,300 (2024) · low 88 (2009)2025

MAUDE reports naming product code MAI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200741000272
20083830172
2009974088
20104122089
20119905129
201265610171
201361350166
20144860149
20155950182
201631910301
201791130478
20181310801,590
201994121,248
202097840957
2021811501,267
2022613601,425
202383401,718
202475302,300
202585402,148
20265691—

What is it indicated for?

The SmartNail™ is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments. The SmartNail™ is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing…

Read the full statement (115 words)

The SmartNail™ is intended for use in the fixation of fragments of fractured non-load bearing bones, osteotomies and arthrodeses, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

The SmartNail™ is not intended for use in and is contraindicated for: 1) Fractures and osteotomies of cortical bone (except cortical bones of the foot and the hand), 2) Fractures and osteotomies in weight bearing cancellous bone, 3) Situations where internal fixation is otherwise contraindicated, e.g., active or potential infection and where patient co-operation cannot be guaranteed (e.g. alcoholism), 4) Treatment of physeal fractures in children, because the effect of SmartNail™ upon the healing of growth plate has not been tested clinically.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K890902

2 other devices cite the same predicate.

  • K043339Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG, 3570LG, 4570LGXtremi-T, LLC · 2005
  • K041288Modification to SmartpinLinvatec Biomaterials, Inc. · 2004

More from Bionx Implants, Ltd.

12 FDA decisions under this applicant name. See the company

  • K030388Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
  • K020056Duet Suture AnchorBionx Implants, Ltd. · 2002
  • K0120001.5MM Bone Fixation KitBionx Implants, Ltd. · 2001
  • K012001SmartscrewBionx Implants, Ltd. · 2001
  • K003077Smartscrew Model 222006...227510Bionx Implants, Ltd. · 2001

Recent decisions in MAI

The MAI category page

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  • K254055OSSIOfiber® Suture AnchorOSSIO, Ltd. · 2026
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https://510kreport.com/device/K993074 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993074: Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993074

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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