510(k) · Cleared

Cleared

Plla Pin

K010983510(k) SpecialCleared Jun 13, 200172-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

Bionx Implants, Inc. · HTY Pin, Fixation, Smooth

Cleared on Jun 13, 2001 after a 72-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 385 later devices descend from it.

Decided: Jun 13, 2001
Review: 72 days
Class: Class II
Product code: HTY
Recalls: None
Predicates: 0

385 later devices descend from it, 4 citing it directly.

This deviceK010983 Plla PinBionx Implants, Inc. · 2001
Descendant · cites it directly · 382 of its ownK031712 Inion Otps Biodegradable PinInion, Ltd. · 2003
Descendant · 2 generations on · 309 of its ownK033717 Transet Fracture Fixation SystemBonutti Research, Inc. · 2004
Descendant · 3 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
Descendant · 4 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
Descendant · 4 generations on · 94 of its ownK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled

Showing 5 of 385 descendants. See all descendants

Descendants cleared per year

2003high 43 (2024) · low 0 (2010)2026

Most influential descendants

Showing 5 of 385 · See all

K031712Inion Otps Biodegradable PinInion, Ltd. · 2003 · cites it directly382descendants
K033717Transet Fracture Fixation SystemBonutti Research, Inc. · 2004 · 2 generations on309descendants
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
K083070Toggleloc SystemBiomet Sports Medicine · 2008 · 4 generations on94descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010983	Plla Pin	Bionx Implants, Inc.	2001	—
+1	K031712	Inion Otps Biodegradable Pin	Inion, Ltd.	2003	—
+2	K033717	Transet Fracture Fixation System	Bonutti Research, Inc.	2004	—
+3	K043248	Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.…	Arthrex, Inc.	2005	—
+4	K052776	Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models…	Arthrex, Inc.	2005	—
+4	K083070	Toggleloc System	Biomet Sports Medicine	2008	6

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	2	0
2005	4	0
2006	3	0
2007	4	0
2008	7	0
2009	5	0
2011	5	0
2012	3	0
2013	8	0
2014	25	0
2015	16	0
2016	9	0
2017	19	0
2018	18	0
2019	31	0
2020	27	0
2021	24	0
2022	25	0
2023	33	0
2024	43	0
2025	34	0
2026	39	0

FIG. 1 — Lineage of K010983, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 14 generations · no Class I recall
#2 Held for the reportin the report
#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? (385)

See all 385

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

Number	Device	Applicant	Decided	Descendants
K031712	Inion Otps Biodegradable Pin	Inion, Ltd.	2003	382
K041288	Modification to Smartpin	Linvatec Biomaterials, Inc.	2004	2
K043339	Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG…	Xtremi-T, LLC	2005	1
K073311	Osteotrans-OT Pin	Takiron Co., Ltd.	2008	0

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, K031712 (Inion, Ltd., 2003) has gone furthest, with 382 descendants of its own.

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

2007high 9 (2010) · low 1 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HTY

90in 2025

2007high 180 (2010) · low 73 (2014)2026

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

Recalls per year · HTY

2in 2022

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	112	0	46
2008	6	86	0	38
2009	2	—	1	36
2010	9	180	1	33
2011	6	82	0	164
2012	4	76	0	129
2013	4	128	0	187
2014	8	73	0	149
2015	8	101	0	121
2016	6	114	2	128
2017	5	127	0	82
2018	4	162	0	138
2019	4	93	1	222
2020	5	108	0	210
2021	5	137	0	148
2022	4	121	2	96
2023	5	146	0	153
2024	1	—	0	297
2025	5	90	0	39
2026	2	—	1	—

https://510kreport.com/device/K010983 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010983: Plla Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010983

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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