510(k) Report

510(k) · Cleared

Cleared

Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG, 3570LG, 4570LG

K043339510(k) TraditionalCleared Apr 18, 2005136-day reviewClass II21 CFR 888.3040

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

Xtremi-T, LLC · HTY Pin, Fixation, Smooth

Cleared on Apr 18, 2005 as substantially equivalent to K010983 (Bionx Implants, Inc., 2001) and 10 other predicates after a 136-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.

Decided
Apr 18, 2005
Review
136 days
Class
Class II
Product code
HTY
Recalls
None
Predicates
11

Its longest line of descent runs back 2 generations to K901456 (1990). 12 ancestors in all, the oldest K864912 (1987). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2001: 3 other ancestors1999: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1989: 1 other ancestor1987: 1 other ancestor1997: 1 other ancestor2015: 1 descendant clearedK901456 · Orthosorb (R) Absorbable Pin · Johnson & Johnson International · 1990K031712 · Inion Otps Biodegradable Pin · Inion, Ltd. · 20031990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant K031712 · Inion Otps Biodegradable Pin · Inion, Ltd. · 2003K901456 · Orthosorb (R) Absorbable Pin · Johnson & Johnson International · 19900
  1. Root · 2 generations backK901456 Orthosorb (R) Absorbable PinJohnson & Johnson International · 1990
  2. 1 generation backK031712 Inion Otps Biodegradable PinInion, Ltd. · 2003
  3. This deviceK043339 Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models…Xtremi-T, LLC · 2005
  4. Descendant · cites it directly · 0 of its ownK151876 Bio2 Fusion Implant SystemBio2 Technologies, Inc. · 2015

Most influential descendants

Showing 1 of 1 · See all
  • K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K901456Orthosorb (R) Absorbable PinJohnson & Johnson International1990—
−1K031712Inion Otps Biodegradable PinInion, Ltd.2003—
0 (this device)K043339Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG…Xtremi-T, LLC2005—
+1K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
198910
199410
199510
199710
199910
200130
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
FIG. 1 — Lineage of K043339, 1990–2015Source: 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 HTY? 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 HTY device

  1. #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (11)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K010983Plla Pin
Summary page 2
…d The substantial equivalence of the ReFIX Pins is based on the use, materials, operational principals, and indications to: DEVICE Manufacturer Trade Name K010983 Bionx PLLA Pin K003659 Bionx PLGA Pin K925098 Bionx Biofix Pin K031712 Inion…
Bionx Implants, Inc.2001—
*K003659Plga Pin, Model 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260
Summary page 2
…ReFIX Pins is based on the use, materials, operational principals, and indications to: DEVICE Manufacturer Trade Name K010983 Bionx PLLA Pin K003659 Bionx PLGA Pin K925098 Bionx Biofix Pin K031712 Inion OTPS Pin K040500 Biomet…
Bionx Implants, Inc.2001—
*K925098Biofix Absorbable Self-Reinforced Poly-L-Lactide
Summary page 2
…ials, operational principals, and indications to: DEVICE Manufacturer Trade Name K010983 Bionx PLLA Pin K003659 Bionx PLGA Pin K925098 Bionx Biofix Pin K031712 Inion OTPS Pin K040500 Biomet Lactonail K011522 Biomet…
Bioscience, Inc.1994—
*K031712Inion Otps Biodegradable Pin
Summary page 2
…tions to: DEVICE Manufacturer Trade Name K010983 Bionx PLLA Pin K003659 Bionx PLGA Pin K925098 Bionx Biofix Pin K031712 Inion OTPS Pin K040500 Biomet Lactonail K011522 Biomet Resorbable Bone Pins K990291…
Inion, Ltd.2003—
*K040500Arthrotek Lactonail
Summary page 2
…Trade Name K010983 Bionx PLLA Pin K003659 Bionx PLGA Pin K925098 Bionx Biofix Pin K031712 Inion OTPS Pin K040500 Biomet Lactonail K011522 Biomet Resorbable Bone Pins K990291 Biomet Lactosorb Bone Pin…
Arthrotek, Inc.2004—
*K011522Resorbable Bone Pins
Summary page 2
…PLLA Pin K003659 Bionx PLGA Pin K925098 Bionx Biofix Pin K031712 Inion OTPS Pin K040500 Biomet Lactonail K011522 Biomet Resorbable Bone Pins K990291 Biomet Lactosorb Bone Pin K953194 Biomet Lactosorb Bon…
Biomet, Inc.2001—
*K990291Lactosorb Bone Pin
Summary page 2
…K925098 Bionx Biofix Pin K031712 Inion OTPS Pin K040500 Biomet Lactonail K011522 Biomet Resorbable Bone Pins K990291 Biomet Lactosorb Bone Pin K953194 Biomet Lactosorb Bone Pin K890902 D&G Biofix Pin K…
Biomet, Inc.19991
*K953194Lactosorb Bone Pin
Summary page 2
…12 Inion OTPS Pin K040500 Biomet Lactonail K011522 Biomet Resorbable Bone Pins K990291 Biomet Lactosorb Bone Pin K953194 Biomet Lactosorb Bone Pin K890902 D&G Biofix Pin K901456 J&J Orthosorb K864912…
Biomet, Inc.1995—
*K890902Biofix* Biodegradable Fixation Rod
Summary page 2
…t Lactonail K011522 Biomet Resorbable Bone Pins K990291 Biomet Lactosorb Bone Pin K953194 Biomet Lactosorb Bone Pin K890902 D&G Biofix Pin K901456 J&J Orthosorb K864912 J&J PDS Pin END OF 510(K) SUMM…
Davis & Geck, Inc.1989—
*K901456Orthosorb (R) Absorbable Pin
Summary page 2
…Resorbable Bone Pins K990291 Biomet Lactosorb Bone Pin K953194 Biomet Lactosorb Bone Pin K890902 D&G Biofix Pin K901456 J&J Orthosorb K864912 J&J PDS Pin END OF 510(K) SUMMARY…
Johnson & Johnson International1990—
*K864912PDS (Polydioxanon) Absorbable Pin
Summary page 2
…91 Biomet Lactosorb Bone Pin K953194 Biomet Lactosorb Bone Pin K890902 D&G Biofix Pin K901456 J&J Orthosorb K864912 J&J PDS Pin END OF 510(K) SUMMARY…
Johnson & Johnson Professionals, Inc.1987—

Also cleared against K010983: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K151876Bio2 Fusion Implant SystemBio2 Technologies, Inc.20150

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 15 years and passes through 3 companies; a new generation was cleared every 13.0 years on median.
  • 1 of the 12 ancestors has a recall of any class.
  • Of its descendants, K151876 (Bio2 Technologies, Inc., 2015) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K010983.

How does its category compare?

All HTY devices

HTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HTY

5in 2025

2007: 62008: 62009: 22010: 92011: 62012: 42013: 42014: 82015: 82016: 62017: 52018: 42019: 42020: 52021: 52022: 42023: 52024: 12025: 52026 (partial year): 2
2007high 9 (2010) · low 1 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HTY

90in 2025

2007: 112 days median2008: 86 days median2010: 180 days median2011: 82 days median2012: 76 days median2013: 128 days median2014: 73 days median2015: 101 days median2016: 114 days median2017: 127 days median2018: 162 days median2019: 93 days median2020: 108 days median2021: 137 days median2022: 121 days median2023: 146 days median2025: 90 days median
2007high 180 (2010) · low 73 (2014)2026

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

Recalls per year · HTY

2in 2022

2009: 12010: 12016: 22019: 12022: 22026 (partial year): 1
2007high 2 (2016) · low 0 (2007)2026

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

Adverse event reports per year · HTY

39in 2025

2007: 462008: 382009: 362010: 332011: 1642012: 1292013: 1872014: 1492015: 1212016: 1282017: 822018: 1382019: 2222020: 2102021: 1482022: 962023: 1532024: 2972025: 39
2007high 297 (2024) · low 33 (2010)2025

MAUDE reports naming product code HTY, 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
20076112046
2008686038
20092—136
20109180133
20116820164
20124760129
201341280187
20148730149
201581010121
201661142128
20175127082
201841620138
20194931222
202051080210
202151370148
20224121296
202351460153
20241—0297
2025590039
20262—1—

What is it indicated for?

ReFIX Biodegradable Pins are intended for use in the fixation and/or alignment of fragments of fractured non-load bearing bones, osteotomies and arthrodeses; and fixation and/or alignment of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments.

For example, ReFIX pins are intended for use in the following procedures:

* fixation of phalangeal fusion and fracture

* repair of metacarpal fusion and fracture

* fixation of hand and wrist fractures

* fixation of metatarsal osteotomies

* correction of hallux valgus

Indications for use as stated in the FDA summary.

Also cleared against K010983

3 other devices cite the same predicate.

  • K073311Osteotrans-OT PinTakiron Co., Ltd. · 2008
  • K041288Modification to SmartpinLinvatec Biomaterials, Inc. · 2004
  • K031712Inion Otps Biodegradable PinInion, Ltd. · 2003

More from Xtremi-T, LLC

2 FDA decisions under this applicant name. See the company

  • K050388Refix Internal Fracture Fixation ScrewsXtremi-T, LLC · 2005

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https://510kreport.com/device/K043339 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043339: Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG, 3570LG, 4570LG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043339

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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