510(k) · Cleared
ClearedCollagen Bone Healing Protective Sheet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Collagen Matrix, Inc. · HRS Plate, Fixation, Bone
Cleared on Oct 25, 2005 as substantially equivalent to K011695 (Collagen Matrix, Inc., 2001) and 3 other predicates after an 89-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Oct 25, 2005
- Review
- 89 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K974017 (1998). 10 ancestors in all, the oldest K960724 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK974017 Timesh SystemSofamor Danek USA,Inc. · 1998 · Recalled
- 2 generations backK994158 Macrosorbos Protective SheetMacropore Biosurgery, Inc. · 2000
- 1 generation backK033918 Ebi Lactosorb Graft Containment SystemEbi, L.P. · 2004
- This deviceK052041 Collagen Bone Healing Protective SheetCollagen Matrix, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K974017 | Timesh System | Sofamor Danek USA,Inc. | 1998 | 1 |
| −2 | K994158 | Macrosorbos Protective Sheet | Macropore Biosurgery, Inc. | 2000 | — |
| −1 | K033918 | Ebi Lactosorb Graft Containment System | Ebi, L.P. | 2004 | — |
| 0 (this device) | K052041 | Collagen Bone Healing Protective Sheet | Collagen Matrix, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
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
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | K011695 | Collagen Dental Membrane | 2001 |
| * | K960724 | Bio-Gide Resorbable Bilayer MembraneSummary page 1…HRS FTM LZN Predicate Device(s): Collagen Dental Membrane, KOI 1695 BioGide". K960724 FBI LactoSorb" Graft Containment System, K033918 MacroPorcOS… | 1997 |
| * | K033918 | Ebi Lactosorb Graft Containment SystemSummary page 1…Collagen Dental Membrane, KOI 1695 BioGide". K960724 FBI LactoSorb" Graft Containment System, K033918 MacroPorcOS Protective Sheet, K994158 Description of the Device The Collagen Bone 1Healing Pr… | 2004 |
| * | K994158 | Macrosorbos Protective SheetSummary page 1…BioGide". K960724 FBI LactoSorb" Graft Containment System, K033918 MacroPorcOS Protective Sheet, K994158 Description of the Device The Collagen Bone 1Healing Protective Sheet is a white. nonfriable, conformable, resorbable, membrane… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 7 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 4 other devices also cite its predicate K011695.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 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 Collagen Bone Healing 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 Collagen Bone Healing Protective Sheet is also indicated for cement restriction in total joint arthroplasty procedures. Only when used in conjunction with traditional rigid fixation, the Collagen Bone Healing Protective Sheet is intended to maintain the…
Read the full statement (170 words)
The Collagen Bone Healing 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 Collagen Bone Healing Protective Sheet is also indicated for cement restriction in total joint arthroplasty procedures.
Only when used in conjunction with traditional rigid fixation, the Collagen Bone Healing 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 Collagen Bone Healing 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 as stated in the FDA summary.
https://510kreport.com/device/K052041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052041: Collagen Bone Healing Protective Sheet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052041
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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