510(k) · Cleared

Cleared

Macrosorbos Protective Sheet

K994158510(k) TraditionalCleared Jul 24, 2000228-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

Macropore Biosurgery, Inc. · HRS Plate, Fixation, Bone

Cleared on Jul 24, 2000 as substantially equivalent to K974017 (Sofamor Danek USA,Inc., 1998) after a 228-day review. Its family tree reaches back 1 generation to 1998. 35 later devices descend from it.

Decided: Jul 24, 2000
Review: 228 days
Class: Class II
Product code: HRS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K974017 (1998). 35 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 1 generation backK974017 Timesh SystemSofamor Danek USA,Inc. · 1998 · Recalled
This deviceK994158 Macrosorbos Protective SheetMacropore Biosurgery, Inc. · 2000
Descendant · cites it directly · 21 of its ownK031961 Inion Otps Biodegradable Mesh Plating SystemInion, Ltd. · 2004
Descendant · 2 generations on · 17 of its ownK123672 Inion Freedomscrew (Alternative Marketing Name: Inion Otps…Inion OY · 2013
Descendant · 3 generations on · 8 of its ownK160304 OsteoBullet Compression ScrewPhalanx Innovations · 2016
Descendant · cites it directly · 7 of its ownK022139 Hip Tool ImplantOrthopedic Sciences, Inc. · 2002
Descendant · 3 generations on · 6 of its ownK193660 OSSIOfiber™ Compression ScrewsOSSIO, Ltd. · 2020

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2001high 4 (2005) · low 0 (2003)2026

Most influential descendants

Showing 5 of 35 · See all

K031961Inion Otps Biodegradable Mesh Plating SystemInion, Ltd. · 2004 · cites it directly21descendants
K123672Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)Inion OY · 2013 · 2 generations on17descendants
K160304OsteoBullet Compression ScrewPhalanx Innovations · 2016 · 3 generations on8descendants
K022139Hip Tool ImplantOrthopedic Sciences, Inc. · 2002 · cites it directly7descendants
K193660OSSIOfiber™ Compression ScrewsOSSIO, Ltd. · 2020 · 3 generations on6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K974017	Timesh System	Sofamor Danek USA,Inc.	1998	1
0 (this device)	K994158	Macrosorbos Protective Sheet	Macropore Biosurgery, Inc.	2000	—
+1	K031961	Inion Otps Biodegradable Mesh Plating System	Inion, Ltd.	2004	—
+2	K123672	Inion Freedomscrew (Alternative Marketing Name: Inion Otps Freedomscrew)	Inion OY	2013	—
+3	K160304	OsteoBullet Compression Screw	Phalanx Innovations	2016	—
+1	K022139	Hip Tool Implant	Orthopedic Sciences, Inc.	2002	—
+3	K193660	OSSIOfiber™ Compression Screws	OSSIO, Ltd.	2020	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2004	3	0
2005	4	0
2006	1	0
2007	3	0
2008	2	0
2012	1	0
2013	1	0
2016	1	0
2018	2	0
2019	2	0
2020	3	0
2021	2	0
2022	2	0
2023	2	0
2024	2	0
2025	1	0
2026	1	0

FIG. 1 — Lineage of K994158, 1998–2026Source: 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 HRS? 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 HRS device

#1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 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
*	K974017	Timesh System Summary page 3 …iples with the following predicate device, which has been determined by FDA to be substantially equivalent to the following pre- amendment devices: Sofamar Danek Timesh (K974017). Indications For Use The MacroPoreOS Protective Sheet shares indications for use with the predicate device as both the MacroPo…	Sofamor Danek USA,Inc.	1998	1

Also cleared against K974017: 6 other devices →

What descends from it? (35)

See all 35

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

Number	Device	Applicant	Decided	Descendants
K031961	Inion Otps Biodegradable Mesh Plating System	Inion, Ltd.	2004	21
K022139	Hip Tool Implant	Orthopedic Sciences, Inc.	2002	7
K033918	Ebi Lactosorb Graft Containment System	Ebi, L.P.	2004	3
K052041	Collagen Bone Healing Protective Sheet	Collagen Matrix, Inc.	2005	0
K011715	Macropore IB Resorbable Plug	Macropore Biosurgery, Inc.	2001	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?

Its one ancestor has a recall.
Of its descendants, K031961 (Inion, Ltd., 2004) has gone furthest, with 21 descendants of its own.
6 other devices also cite its predicate K974017.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007high 144 (2022) · low 57 (2014)2026

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

Recalls per year · HRS

1in 2025

2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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	35	63	2	339
2008	35	87	11	311
2009	47	85	3	435
2010	49	100	16	491
2011	43	88	5	773
2012	59	106	4	1,663
2013	56	89	11	2,643
2014	76	57	0	2,413
2015	56	97	7	3,095
2016	44	109	5	2,276
2017	57	122	3	2,220
2018	40	116	2	2,663
2019	46	89	25	3,359
2020	48	88	1	2,790
2021	40	87	9	2,442
2022	47	144	3	1,700
2023	40	120	1	2,049
2024	54	96	0	1,849
2025	54	90	1	2,306
2026	51	82	3	—

What is it indicated for?

The MacroPoreOS Protective Sheet is intended to maintain the relative position of weak bony tissue such as bone grafts, bone graft substitutes, or bone fragments from comminuted fractures. The MacroPoreOS Protective sheet is also indicated for cement restriction in total joint arthroplasty procedures. Only when used in conjunction with traditional rigid fixation, the MacroPoreOS Protective Sheet is intended to maintain the relative position of weak bony…

Read the full statement (154 words)

Only when used in conjunction with traditional rigid fixation, the MacroPoreOS Protective Sheet is intended to maintain the relative position of weak bony tissue in trauma and reconstructive orthopedic procedures involving:

Long bones

Flat bones

Short bones

Irregular bones

Appendicular skeleton

Thorax

When used alone (without traditional rigid fixation), the MacroPoreOS Protective Sheet is intended to maintain the relative position of bone grafts or bone graft substitutes in reconstructive orthopedic procedures involving:

Tumor resections where bone strength has not been compromised

Iliac crest harvests

This device is not intended for use in the spine. The device is not intended for load bearing indications unless used in conjunction with traditional rigid fixation.

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

https://510kreport.com/device/K994158 · printed Nov 4, 2026

Cite this page

510(k) Report. “K994158: Macrosorbos Protective Sheet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994158

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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