510(k) · Cleared
ClearedLocking Bone Screw Model HCQ04, HCZ04
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Changzhou Orthmar Medical Instrument Co., Ltd. · HWC Screw, Fixation, Bone
Cleared on Nov 23, 2010 as substantially equivalent to K081513 (Merete Medical GmbH, 2008) after a 253-day review. Its family tree reaches back 6 generations to 1998. 13 later devices descend from it.
- Decided
- Nov 23, 2010
- Review
- 253 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K981372 (1998). 14 ancestors in all. 13 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 5 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 4 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 3 generations backK050457 Merete Metafix Small Fragment Bone Plate SystemMerete Medical GmbH · 2005
- 2 generations backK063487 Merete BLP Small Fragment Locking Bone PlateMerete Medical GmbH · 2007
- 1 generation backK081513 Merete 3.0 and 3.5 MM Locking ScrewsMerete Medical GmbH · 2008
- This deviceK100721 Locking Bone Screw Model HCQ04, HCZ04Changzhou Orthmar Medical Instrument Co., Ltd. · 2010
- Descendant · cites it directly · 7 of its ownK130340 Locking Bone Plates and ScrewsWeigao Orthopaedic Device Co., Ltd. · 2013
- Descendant · 2 generations on · 2 of its ownK133840 Kangli Locking Plate SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK143002 Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd. · 2015
- Descendant · 2 generations on · 1 of its ownK150009 BaideJiangsu Baide Medical Intrument Co., Ltd. · 2015
- Descendant · cites it directly · 1 of its ownK131759 Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd. · 2013
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K130340Locking Bone Plates and ScrewsWeigao Orthopaedic Device Co., Ltd. · 2013 · cites it directly7descendants
- K133840Kangli Locking Plate SystemSuzhou Kangli Orthopaedics Instrument Co., Ltd. · 2014 · 2 generations on2descendants
- K143002Metallic Locking Bone Plate and Screw SystemChangzhou Dingjian Medical Appliance Co., Ltd. · 2015 · 2 generations on1descendant
- K150009BaideJiangsu Baide Medical Intrument Co., Ltd. · 2015 · 2 generations on1descendant
- K131759Metallic Locking Compression Bone Plates and Screws SystemTianjin Walkman Biomaterial Co., Ltd. · 2013 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −5 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −4 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −3 | K050457 | Merete Metafix Small Fragment Bone Plate System | Merete Medical GmbH | 2005 | — |
| −2 | K063487 | Merete BLP Small Fragment Locking Bone Plate | Merete Medical GmbH | 2007 | — |
| −1 | K081513 | Merete 3.0 and 3.5 MM Locking Screws | Merete Medical GmbH | 2008 | — |
| 0 (this device) | K100721 | Locking Bone Screw Model HCQ04, HCZ04 | Changzhou Orthmar Medical Instrument Co., Ltd. | 2010 | — |
| +1 | K130340 | Locking Bone Plates and Screws | Weigao Orthopaedic Device Co., Ltd. | 2013 | — |
| +2 | K133840 | Kangli Locking Plate System | Suzhou Kangli Orthopaedics Instrument Co., Ltd. | 2014 | — |
| +2 | K143002 | Metallic Locking Bone Plate and Screw System | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015 | — |
| +2 | K150009 | Baide | Jiangsu Baide Medical Intrument Co., Ltd. | 2015 | — |
| +1 | K131759 | Metallic Locking Compression Bone Plates and Screws System | Tianjin Walkman Biomaterial Co., Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K081513 | Merete 3.0 and 3.5 MM Locking ScrewsSummary page 2…e proposed device, Locking Bone Screw, is determined to be Substantially Equivalent (SE) to the predicate device, Merete 3.5mim Locking Screws as cleared under K0815 13. 7. Non-Clinical Test Conclusion Bench tests were conducted to verify that the proposed device met all design specific… | 2008 |
What descends from it? (13)
See all 136 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130340 | Locking Bone Plates and Screws | 2013 | 7 |
| K131759 | Metallic Locking Compression Bone Plates and Screws System | 2013 | 1 |
| K162380 | Locking Plate System | 2017 | 0 |
| K151508 | IRENE Locking Compression Plate System | 2016 | 0 |
| K132642 | Locking Plate System | 2013 | 0 |
| K112798 | Locking Compression Plate System | 2012 | 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?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 14 ancestors have a recall of any class.
- Of its descendants, K130340 (Weigao Orthopaedic Device Co., Ltd., 2013) has gone furthest, with 7 descendants of its own.
- 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. 2010, 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?
Locking Bone Screw is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100721: Locking Bone Screw Model HCQ04, HCZ04.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100721
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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