510(k) · Cleared
Recalled · Class II · 2015Acufex Mosaicplasty Comprehensive System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Endoscopy, Inc. · HRX Arthroscope
Cleared on Dec 20, 1996 after a 59-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Dec 20, 1996
- Review
- 59 days
- Class
- Class II
- Product code
- HRX
- Recalls
- 4
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK964215 Acufex Mosaicplasty Comprehensive SystemSmith & Nephew Endoscopy, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK051656 Oct (Osteochondral Transplant) Comprehensive SystemOsteobiologics, Inc. · 2005
Most influential descendants
Showing 1 of 1 · See all- K051656Oct (Osteochondral Transplant) Comprehensive SystemOsteobiologics, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964215 | Acufex Mosaicplasty Comprehensive System | Smith & Nephew Endoscopy, Inc. | 1996 | — |
| +1 | K051656 | Oct (Osteochondral Transplant) Comprehensive System | Osteobiologics, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 HRX? 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 HRX device
- #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (12)
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 |
|---|---|---|---|
| * | — | Drill Guide (Synthes®) Named without a submission number | |
| * | — | Drill Sleeves (Synthes) Named without a submission number | |
| * | — | 2.7 mm Arthr. Drill (Synthes) Named without a submission number | |
| * | — | Arthr. Reamer Drills Named without a submission number | |
| * | — | Gouges (Synthes) Named without a submission number | |
| * | — | Trephine Drills (Smith & Nephew Endoscopy) Named without a submission number | |
| * | — | Tamps (Zimmer®) Named without a submission number | |
| * | — | Bone Grafter Instrument (Makar®) Named without a submission number | |
| * | — | Arthr. Transfer Tubes (Makar®) Named without a submission number | |
| * | — | Quick Coupling Adapter (Synthes) Named without a submission number | |
| * | — | Bone Compression Forceps (KMedic®) Named without a submission number | |
| * | — | Metal Cannula (Smith & Nephew Endoscopy) Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051656 | Oct (Osteochondral Transplant) Comprehensive System | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 10, 2015 | Class II | Z-0158-2016 | Package design/selection | Sterility of device is compromised due to breach in the packaging |
| Sep 10, 2015 | Class II | Z-0155-2016 | Package design/selection | Sterility of device is compromised due to breach in the packaging |
| Sep 10, 2015 | Class II | Z-0156-2016 | Package design/selection | Sterility of device is compromised due to breach in the packaging |
| Sep 10, 2015 | Class II | Z-0157-2016 | Package design/selection | Sterility of device is compromised due to breach in the packaging |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051656 (Osteobiologics, Inc., 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HRX devicesHRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRX
107in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRX
2,076in 2025
MAUDE reports naming product code HRX, 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 | 7 | 89 | 3 | 421 |
| 2008 | 9 | 115 | 13 | 441 |
| 2009 | 11 | 139 | 23 | 558 |
| 2010 | 9 | 114 | 12 | 612 |
| 2011 | 3 | 84 | 6 | 631 |
| 2012 | 11 | 102 | 0 | 778 |
| 2013 | 12 | 90 | 4 | 678 |
| 2014 | 9 | 140 | 0 | 802 |
| 2015 | 4 | 132 | 7 | 763 |
| 2016 | 8 | 89 | 0 | 469 |
| 2017 | 4 | 97 | 0 | 934 |
| 2018 | 12 | 101 | 1 | 1,581 |
| 2019 | 12 | 45 | 0 | 1,676 |
| 2020 | 7 | 141 | 0 | 1,706 |
| 2021 | 7 | 57 | 3 | 1,908 |
| 2022 | 3 | 89 | 0 | 1,406 |
| 2023 | 4 | 249 | 0 | 1,852 |
| 2024 | 6 | 110 | 1 | 2,427 |
| 2025 | 9 | 107 | 0 | 2,076 |
| 2026 | 7 | 217 | 0 | — |
What is it indicated for?
The Acufex® MosaicPlasty™ Comprehensive System is indicated for arthroscopic (knee and ankle) and open osteochondral grafting for the treatment of osteochondral (cartilage) defects.
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/K964215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964215: Acufex Mosaicplasty Comprehensive System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964215
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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