510(k) · Cleared
ClearedMetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws
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 Feb 12, 2016 as substantially equivalent to K081513 (Merete Medical GmbH, 2008) and 6 other predicates after a 191-day review. Its family tree reaches back 8 generations to 1998.
- Decided
- Feb 12, 2016
- Review
- 191 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 8 generations to K981372 (1998). 47 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 8 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 7 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 6 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 5 generations backK050457 Merete Metafix Small Fragment Bone Plate SystemMerete Medical GmbH · 2005
- 4 generations backK063487 Merete BLP Small Fragment Locking Bone PlateMerete Medical GmbH · 2007
- 3 generations backK081513 Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH · 2008
- 2 generations backK090063 Merete Locking Bone Plate SystemMerete Medical, Inc. · 2009
- 1 generation backK120787 Merete Locking Bone Plate System IiiMerete Medical GmbH · 2012
- This deviceK152187 MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical…Merete Medical GmbH · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −7 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −6 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −5 | K050457 | Merete Metafix Small Fragment Bone Plate System | Merete Medical GmbH | 2005 | — |
| −4 | K063487 | Merete BLP Small Fragment Locking Bone Plate | Merete Medical GmbH | 2007 | — |
| −3 | K081513 | Merete 3.0 and 3.5 MM Locking Screws | Merete Medical GmbH | 2008 | — |
| −2 | K090063 | Merete Locking Bone Plate System | Merete Medical, Inc. | 2009 | — |
| −1 | K120787 | Merete Locking Bone Plate System Iii | Merete Medical GmbH | 2012 | — |
| 0 (this device) | K152187 | MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws… | Merete Medical GmbH | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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? (7)
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 |
|---|---|---|---|
| * | K081513 | Merete 3.0 and 3.5 MM Locking ScrewsSummary page 5…FR 888.3030 Device Product Code: HWC, HRS Proposed Regulatory Class: Class II Legally marketed Devices to which substantial Equivalence is claimed: K081513 Merete 3.0 and 3.5 mm Locking Screws K120787 Merete Locking Bone Plate System III K140069 Locking Bone Plate Style… | 2008 |
| * | K120787 | Merete Locking Bone Plate System IiiSummary page 5…HRS Proposed Regulatory Class: Class II Legally marketed Devices to which substantial Equivalence is claimed: K081513 Merete 3.0 and 3.5 mm Locking Screws K120787 Merete Locking Bone Plate System III K140069 Locking Bone Plate Style 14, MetaFix Locking Screw 3.8, Merete Cannulated… | 2012 |
| * | K140069 | Locking Bone Plate Style 14, Metafix Locking Screw 3.8, Merete Cannulated PCS 3.0Summary page 5…Legally marketed Devices to which substantial Equivalence is claimed: K081513 Merete 3.0 and 3.5 mm Locking Screws K120787 Merete Locking Bone Plate System III K140069 Locking Bone Plate Style 14, MetaFix Locking Screw 3.8, Merete Cannulated PCS 3.0 K130400 Meretec CS, Cortical Screws K… | 2014 |
| * | K130400 | Meretec CS, Cortical ScrewsSummary page 5…nd 3.5 mm Locking Screws K120787 Merete Locking Bone Plate System III K140069 Locking Bone Plate Style 14, MetaFix Locking Screw 3.8, Merete Cannulated PCS 3.0 K130400 Meretec CS, Cortical Screws K091798 Merete Compression Screws K050924 Merete DuoThreadTM Bone Screw K051323 M… | 2013 |
| * | K091798 | Merete Compression ScrewsSummary page 5…ete Locking Bone Plate System III K140069 Locking Bone Plate Style 14, MetaFix Locking Screw 3.8, Merete Cannulated PCS 3.0 K130400 Meretec CS, Cortical Screws K091798 Merete Compression Screws K050924 Merete DuoThreadTM Bone Screw K051323 Merete Twistcut Snap-Off Bone Screw Devic… | 2009 |
| * | K050924 | Merete Duothreadtm Bone ScrewSummary page 5…69 Locking Bone Plate Style 14, MetaFix Locking Screw 3.8, Merete Cannulated PCS 3.0 K130400 Meretec CS, Cortical Screws K091798 Merete Compression Screws K050924 Merete DuoThreadTM Bone Screw K051323 Merete Twistcut Snap-Off Bone Screw Device Description: MetaFix™ LS Locking Scre… | 2005 |
| * | K051323 | Merete Twistcut Snap-Off Bone ScrewSummary page 5…x Locking Screw 3.8, Merete Cannulated PCS 3.0 K130400 Meretec CS, Cortical Screws K091798 Merete Compression Screws K050924 Merete DuoThreadTM Bone Screw K051323 Merete Twistcut Snap-Off Bone Screw Device Description: MetaFix™ LS Locking Screws The screws are fully threaded and self-t… | 2005 |
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 18 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 6 of the 47 ancestors have a recall of any class.
- 4 other devices also cite its predicate K081513.
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?
Indications for use include fixation of fractures. For specific screw indications please see below. MetaFix™ LS Locking Screws • For adult and pediatric patients • In combination with Merete Locking Plates • Fixation of fractures, osteotomies, non unions of the clavicle, scapula, olecranon, radius, ulna, fibula, metacarpals, metatarsals • Hallux Valgus osteotomy correction, middle hand and middle foot bones and particular in osteopenic bone Merete®…
Read the full statement (247 words)
Indications for use include fixation of fractures. For specific screw indications please see below.
MetaFix™ LS Locking Screws
• For adult and pediatric patients
• In combination with Merete Locking Plates
• Fixation of fractures, osteotomies, non unions of the clavicle, scapula, olecranon, radius, ulna, fibula, metacarpals, metatarsals
• Hallux Valgus osteotomy correction, middle hand and middle foot bones and particular in osteopenic bone
Merete® Cannulated PCS
• For adult and pediatric patients
• Fixation of fresh fractures
• Revision procedures
• Joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes
Merete® CS Cortical Screws
• For adult and pediatric patients
• Fixation of fresh fractures
• Revision procedures
• Joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes
Merete® Cannulated HCS
• Fixation of fractures and reconstruction of various bones
• Osteotomies in the foot (as Hallux Valgus) or hand
• Athrodesis in hand, foot or ankle surgery
• Fixation of bone fragments in long bones or small bone fractures
DuoThread™ Scarf Screws
• Small bone fracture fixation
• Fixation and stabilization of bones of the feet
• Osteotomies (Scarf-Osteotomy, Chevron-Austin Osteotomy, Akin-Osteotomy, Closing Wedge Osteotomy)
• Fusion (MPG-Athrodesis)
• Fixation of almost all common osteotomies of the first metatarsal
TwistCut™ Snap-Off Screws
• Fixation of fractures and reconstruction of bones
• Fixation of small bone fragments
• Mono cortical fixation
• Osteotomies (Weil-Osteotomy)
• Fracture fixation in the foot and hand
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152187 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152187: MetaFix LS Locking Screws, Merete Cannulated PCS, Merete CS Cortical Screws, Merete Cannulated HCS, DuoThread Scarf Screws and TwistCut Snap-Off Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152187
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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