510(k) Report

510(k) · Cleared

Cleared

Biofix Bioabsorabable Self-Reinforced Poly-L-Lactide, Threaded Fixation Rod

K952471510(k) TraditionalCleared Aug 7, 199573-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

Bioscience, Inc. · MAI Fastener, Fixation, Biodegradable, Soft Tissue

Cleared on Aug 7, 1995 after a 73-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 501 later devices descend from it.

Decided
Aug 7, 1995
Review
73 days
Class
Class II
Product code
MAI
Recalls
None
Predicates
0

501 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 1998: 2 descendants cleared2001: 2 descendants cleared1999: 3 descendants cleared2002: 6 descendants cleared2004: 5 descendants cleared2005: 5 descendants cleared2003: 2 descendants cleared2008: 9 descendants cleared2006: 6 descendants cleared2013: 14 descendants cleared2015: 12 descendants cleared2007: 4 descendants cleared2018: 20 descendants cleared2019: 34 descendants cleared2017: 22 descendants cleared2011: 10 descendants cleared2020: 30 descendants cleared2024: 52 descendants cleared2025: 54 descendants cleared2014: 22 descendants cleared2021: 29 descendants cleared2012: 7 descendants cleared2022: 32 descendants cleared2026: 50 descendants cleared2016: 10 descendants cleared2009: 9 descendants cleared2023: 46 descendants cleared2010: 4 descendants cleared1995200020052010201520202025
  1. This deviceK952471 Biofix Bioabsorabable Self-Reinforced Poly-L-Lactide, Threaded…Bioscience, Inc. · 1995
  2. Descendant · cites it directly · 413 of its ownK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
  3. Descendant · cites it directly · 337 of its ownK012001 SmartscrewBionx Implants, Ltd. · 2001
  4. Descendant · 2 generations on · 333 of its ownK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
  5. Descendant · 3 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
  6. Descendant · 4 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005

Showing 5 of 501 descendants. See all descendants

Descendants cleared per year

1998: 21999: 32001: 22002: 62003: 22004: 52005: 52006: 62007: 42008: 92009: 92010: 42011: 102012: 72013: 142014: 222015: 122016: 102017: 222018: 202019: 342020: 302021: 292022: 322023: 462024: 522025: 542026: 50
1998high 54 (2025) · low 0 (2000)2026

Most influential descendants

Showing 5 of 501 · See all
  • K992947Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999 · cites it directly413descendants
  • K012001SmartscrewBionx Implants, Ltd. · 2001 · cites it directly337descendants
  • K030900Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003 · 2 generations on333descendants
  • K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · 3 generations on306descendants
  • K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 4 generations on217descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952471Biofix Bioabsorabable Self-Reinforced Poly-L-Lactide, Threaded Fixation RodBioscience, Inc.1995—
+1K992947Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd.1999—
+1K012001SmartscrewBionx Implants, Ltd.2001—
+2K030900Inion Otps Biodegradable Fixaton SystemInion, Ltd.2003—
+3K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.…Arthrex, Inc.2005—
+4K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models…Arthrex, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
199930
200120
200260
200320
200450
200550
200660
200740
200890
200990
201040
2011100
201270
2013140
2014220
2015120
2016100
2017220
2018200
2019340
2020300
2021290
2022320
2023460
2024520
2025540
2026500
FIG. 1 — Lineage of K952471, 1995–2026Source: 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), 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.

Top candidate predicates for a new MAI device

  1. #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (501)

See all 501

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

NumberDeviceApplicantDecidedDescendants
K992947Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd.1999413
K012001SmartscrewBionx Implants, Ltd.2001337
K972919Biofix Bioabsorbable Self-Reinforced Poly-L-Lactide Threaded Browlift ScrewBionx Implants, Inc.199887
K023022Nugen FX ScrewBionx Implants, Inc.20022
K020222Wisorb Malleolar ScrewCambridge Scientific, Inc.20022
K032447Cannulated Nugen FX Screw Fully Threaded, Cannulated Nugen FX Screw Partially ThreadedLinvatec Biomaterials, Ltd.20041

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?

  • Of its descendants, K992947 (Bionx Implants, Ltd., 1999) has gone furthest, with 413 descendants of its own.

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—

More from Bioscience, Inc.

4 FDA decisions under this applicant name. See the company

  • K955768Biofix Biodegradable Meniscus Arrow SystemBioscience, Inc. · 1996
  • K955003Biofix Biodegradable Self-Reinforced Poly-L-Lactide (SR-Plla) Mini-TackBioscience, Inc. · 1996
  • K925098Biofix Absorbable Self-Reinforced Poly-L-LactideBioscience, Inc. · 1994

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https://510kreport.com/device/K952471 · printed Nov 5, 2026

Cite this page

510(k) Report. “K952471: Biofix Bioabsorabable Self-Reinforced Poly-L-Lactide, Threaded Fixation Rod.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K952471

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026