510(k) · Cleared
ClearedTaperloc Complete, Size 5 and 6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing Corp · KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Cleared on Jan 21, 2011 as substantially equivalent to K101086 (Biomet, Inc., 2010) after a 29-day review. Its family tree reaches back 1 generation to 2010. 48 later devices descend from it.
- Decided
- Jan 21, 2011
- Review
- 29 days
- Class
- Class III
- Product code
- KWA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K101086 (2010). 48 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK101086 Taperloc CompleteBiomet, Inc. · 2010
- This deviceK103755 Taperloc Complete, Size 5 and 6Biomet Manufacturing Corp · 2011
- Descendant · cites it directly · 34 of its ownK110400 Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011
- Descendant · cites it directly · 20 of its ownK121935 Taperset Hip Small StemsConsensus Orthopedics, Inc. · 2012
- Descendant · 2 generations on · 19 of its ownK161184 iNSitu Total Hip SystemTheken Companies, LLC · 2016
- Descendant · cites it directly · 14 of its ownK120030 Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp · 2012
- Descendant · 2 generations on · 11 of its ownK121034 Ioi Total HipIconacy Orthopedic Implants, LLC · 2012
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K110400Taperloc Complete Microplasty StemBiomet Manufacturing Corp · 2011 · cites it directly34descendants
- K121935Taperset Hip Small StemsConsensus Orthopedics, Inc. · 2012 · cites it directly20descendants
- K161184iNSitu Total Hip SystemTheken Companies, LLC · 2016 · 2 generations on19descendants
- K120030Taperloc Complete Size 4MM and XR 123Biomet Manufacturing Corp · 2012 · cites it directly14descendants
- K121034Ioi Total HipIconacy Orthopedic Implants, LLC · 2012 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K101086 | Taperloc Complete | Biomet, Inc. | 2010 | — |
| 0 (this device) | K103755 | Taperloc Complete, Size 5 and 6 | Biomet Manufacturing Corp | 2011 | — |
| +1 | K110400 | Taperloc Complete Microplasty Stem | Biomet Manufacturing Corp | 2011 | — |
| +1 | K121935 | Taperset Hip Small Stems | Consensus Orthopedics, Inc. | 2012 | — |
| +2 | K161184 | iNSitu Total Hip System | Theken Companies, LLC | 2016 | — |
| +1 | K120030 | Taperloc Complete Size 4MM and XR 123 | Biomet Manufacturing Corp | 2012 | — |
| +2 | K121034 | Ioi Total Hip | Iconacy Orthopedic Implants, LLC | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 6 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 6 | 0 |
| 2025 | 2 | 0 |
| 2026 | 7 | 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 KWA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K101086 | Taperloc CompleteSummary page 2…(hemi-hip) metal/polymer cemented or uncemented prosthesis (21 CFR §888.3390) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Taperloc® Complete, K101086 Device Description: The Taperloc® Complete hip stems are a line extension of the legally marketed Taperloc® Complete stems clea… | 2010 |
What descends from it? (48)
See all 488 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110400 | Taperloc Complete Microplasty Stem | 2011 | 34 |
| K121935 | Taperset Hip Small Stems | 2012 | 20 |
| K120030 | Taperloc Complete Size 4MM and XR 123 | 2012 | 14 |
| K163577 | Ecofit® Hip System | 2017 | 9 |
| K183684 | Libertas – Taper Uncemented Femoral Stem | 2019 | 1 |
| K140674 | Exactech Tapered Wedge Femoral Stem | 2014 | 1 |
| K251270 | Taperloc® Complete Hip Stem | 2026 | 0 |
| K183532 | Latitud Hip Replacement System | 2019 | 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?
How does its category compare?
All KWA devicesKWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KWA
4in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · KWA
76in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWA
19in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWA
1,216in 2025
MAUDE reports naming product code KWA, 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 | 8 | 74 | 0 | 213 |
| 2008 | 9 | 57 | 13 | 762 |
| 2009 | 7 | 139 | 0 | 820 |
| 2010 | 6 | 167 | 84 | 3,348 |
| 2011 | 11 | 101 | 28 | 17,737 |
| 2012 | 4 | 76 | 21 | 24,601 |
| 2013 | 0 | — | 1 | 20,020 |
| 2014 | 0 | — | 0 | 16,494 |
| 2015 | 0 | — | 0 | 12,339 |
| 2016 | 0 | — | 1 | 7,872 |
| 2017 | 0 | — | 1 | 6,847 |
| 2018 | 0 | — | 1 | 6,388 |
| 2019 | 0 | — | 2 | 7,628 |
| 2020 | 0 | — | 1 | 4,538 |
| 2021 | 0 | — | 0 | 2,064 |
| 2022 | 0 | — | 0 | 1,617 |
| 2023 | 0 | — | 19 | 1,474 |
| 2024 | 0 | — | 0 | 1,168 |
| 2025 | 0 | — | 0 | 1,216 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5. Revision procedures where other treatment or devices have failed.
Porous coated components are intended for uncemented biological fixation.
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/K103755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103755: Taperloc Complete, Size 5 and 6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103755
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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