510(k) · Cleared

Recalled · 2007

Solar Purefix HA Shoulder

K061677510(k) SpecialCleared Jul 10, 200625-day reviewClass II21 CFR 888.3690Recalls 1

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

Howmedica Osteonics Corp. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Cleared on Jul 10, 2006 as substantially equivalent to K955731 (Osteonics Corp., 1996) after a 25-day review. Its family tree reaches back 1 generation to 1996. It has been recalled once.

Decided: Jul 10, 2006
Review: 25 days
Class: Class II
Product code: HSD
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K955731 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK955731 Osteonics Shoulder Humeral ComponentsOsteonics Corp. · 1996 · Recalled
This deviceK061677 Solar Purefix HA ShoulderHowmedica Osteonics Corp. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K955731	Osteonics Shoulder Humeral Components	Osteonics Corp.	1996	1
0 (this device)	K061677	Solar Purefix HA Shoulder	Howmedica Osteonics Corp.	2006	—

FIG. 1 — Lineage of K061677, 1996–2006Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 HSD? 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 HSD device

#1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 16 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? (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	Applicant	Decided	Recalls
*	K955731	Osteonics Shoulder Humeral Components Summary page 2 …ications for use, intended use, design and sterilization to the Solar® Shoulder (K95573 1, cleared March 05, 1996). 4 DEPARTMENT OF HEALTH & HUMA…	Osteonics Corp.	1996	1

Also cleared against K955731: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 15, 2007	Not classified	Z-1236-2008	Process control	Delamination: Loosening of the titanium plasma coating on the product was observed on twelve non-distributed units.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has a recall.
3 other devices also cite its predicate K955731.

How does its category compare?

All HSD devices

HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSD

1in 2024

2007high 4 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSD

145in 2016

2007high 218 (2013) · low 72 (2007)2026

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

Recalls per year · HSD

1in 2020

2007high 3 (2017) · low 0 (2007)2026

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

Adverse event reports per year · HSD

757in 2025

2007high 985 (2017) · low 128 (2007)2025

MAUDE reports naming product code HSD, 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	4	72	0	128
2008	3	92	2	259
2009	0	—	2	156
2010	0	—	0	225
2011	2	—	0	241
2012	2	—	0	254
2013	4	218	0	288
2014	1	—	0	434
2015	0	—	0	574
2016	3	145	0	784
2017	0	—	3	985
2018	1	—	1	649
2019	0	—	0	830
2020	2	—	1	658
2021	0	—	0	573
2022	1	—	0	508
2023	0	—	0	586
2024	1	—	0	693
2025	0	—	0	757
2026	0	—	0	—

What is it indicated for?

For use as a Bipolar Shoulder Replacement: * Aseptic necrosis of the humeral head. * Painful, disabling joint disease of the shoulder resulting from: Degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis. * Proximal humeral fracture and/or dislocation. * Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results. · Pathological conditions or age considerations…

Read the full statement (144 words)

For use as a Bipolar Shoulder Replacement:

* Aseptic necrosis of the humeral head.

* Painful, disabling joint disease of the shoulder resulting from:

Degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.

* Proximal humeral fracture and/or dislocation.

* Clinical management problems where arthrodesis or alternative

reconstructive techniques are less likely to achieve satisfactory results.

· Pathological conditions or age considerations which indicate a more conservative

glenoid procedure and avoidance of the use of bone cement in the glenoid.

For use as a Total Shoulder Replacement:

* Aseptic necrosis of the humeral head.

* Painful, disabling joint disease of the shoulder resulting from:

Degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.

* Proximal humeral fracture and/or dislocation.

* Clinical management problems where arthrodesis or alternative reconstructive

techniques are less likely to achieve satisfactory results.

* Revision of previous unsuccessful total shoulder replacement, resurfacing or other

procedure.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061677 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061677: Solar Purefix HA Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061677

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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