510(k) · Cleared
ClearedMC-Subtalar (TM) II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merete Medical GmbH · HWC Screw, Fixation, Bone
Cleared on Apr 29, 2016 as substantially equivalent to K133035 (Normed Medizin-Technik GmbH, 2013) after a 60-day review. Its family tree reaches back 8 generations to 1980.
- Decided
- Apr 29, 2016
- Review
- 60 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K792670 (1980). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK792670 Smith Subtalar PegDow Corning Wright · 1980
- 7 generations backK960692 Subtalar Mba SystemKinetikos Medical, Inc. · 1996
- 6 generations backK051611 Mbaresorb ImplantKinetikos Medical, Inc. · 2005 · Recalled
- 5 generations backK071456 Arthrex Prostop Plus Arthroereisis Subtalar ImplantArthrex, Inc. · 2008
- 4 generations backK093820 Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090…Memometal Technologies · 2010
- 3 generations backK103183 Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · Recalled
- 2 generations backK111834 Disco Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · Recalled
- 1 generation backK133035 Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH · 2013
- This deviceK160548 MC-Subtalar (TM) IIMerete Medical GmbH · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K792670 | Smith Subtalar Peg | Dow Corning Wright | 1980 | — |
| −7 | K960692 | Subtalar Mba System | Kinetikos Medical, Inc. | 1996 | — |
| −6 | K051611 | Mbaresorb Implant | Kinetikos Medical, Inc. | 2005 | 3 |
| −5 | K071456 | Arthrex Prostop Plus Arthroereisis Subtalar Implant | Arthrex, Inc. | 2008 | — |
| −4 | K093820 | Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115 | Memometal Technologies | 2010 | — |
| −3 | K103183 | Trilliant Surgical Subtalar Implant | Trilliant Surgical, Ltd. | 2011 | 1 |
| −2 | K111834 | Disco Subtalar Implant | Trilliant Surgical, Ltd. | 2011 | 1 |
| −1 | K133035 | Normed Pellegrin Calcaneus Stop Screw | Normed Medizin-Technik GmbH | 2013 | — |
| 0 (this device) | K160548 | MC-Subtalar (TM) II | Merete Medical GmbH | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2008 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K133035 | Normed Pellegrin Calcaneus Stop ScrewSummary page 4…er – 888.3040 Device Product Code: HWC Proposed Regulatory Class: Class II Legally marketed Devices to which substantial Equivalence is claimed: K133035 Pellegrin Calcaneus Stop Screw, Normed Medizin-Technik GmbH Reference devices: K111834 Disco Subtalar Implant,… | 2013 |
| † | K111834 | Disco Subtalar Implant | 2011 |
| † | K152187 | MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete… | 2016 |
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 36 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 17 ancestors have a recall of any class.
- 1 other device also cites its predicate K133035.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The MC-Subtalar™ II screw system is for the correction of flexible flat feet in children (6 to < 12 years of age) and adolescence (12 to < 13 years of age). It is intended to block medial and plantar pronation of the talus, while, allowing normal subtalar joint motion.
Specific indications for use include:
Flexible flat feet in children and adolescence,
Progression medial talus protrusion,
Loss of longitudinal arch,
Pain along the tibialis posterior,
Age > 6 years, after conservative treatment did not result in a flat foot correction,
Age < 13 years, while the deformity may be corrected manually.
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/K160548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160548: MC-Subtalar (TM) II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160548
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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